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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG; BLOOD SPECIMEN COLLECTION DEVICE
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| Catalog Number 362799 |
| Device Problem
Incorrect Measurement (1383)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/10/2022 |
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Event Type
malfunction
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Event Description
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It was reported when using the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg, the user complaint of the instruments clogging with micro-clots.The following information was provided by the initial reporter.The customer stated: "we had a call from our client and they have raised an issue with recently received 362799 tubes.Since around october last year (they¿ve been using these bd tubes for years) they¿ve noticed that their instruments started clogging with micro clots or fibrin.These formations are not visible to the naked eye, but they accumulate in the instrument needle and clog it in time.It¿s from one department where donors are tested, so first thing the personnel has been debriefed and received additional training to recap the correct blood collection with the emphasis on the inversions, even a shaker/rotator has been placed on site to mix the blood straight after collection, however nothing has changed.I am sending some pictures of the part showing the dirt.It definitely is fibrin, as they¿ve asked pathology lab to investigate it and they confirmed this was fibrin.Nothing can be seen with a naked eye in the tubes after centrifugation before analysis.Sometimes they can see a film of some fatty substance on top of plasma, but it happens very rarely and they remove it before analysis." bd nordic asked if the clots are present when they receive the samples in the lab or if they appear during analysis in the instrument and this is the reply we got: "here is the comment from the engineer: the part is ¿vacuum manifold¿.This part is connected to 10 hoses from two magwash washing stations (five hoses from each station) and a waste hose coming from a liquid waste tank.There is always a vacuum in the liquid waste tank, vacuum manifold, and magwash station probes.Mtu tubes are washed at the magwash station.Unnecessary test substance is removed during washing.Magwash reagent is added to the tube for washing, and the descending probes (because of the negative pressure in them) aspirate the liquid.The liquid travels to the vacuum manifold, and from it the thick waste hose travels to the liquid waste container.".
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1014030.Medical device expiration date: 2022-01-31.Device manufacture date: 2021-01-14.Medical device lot #: 1040866.Medical device expiration date: 2022-02-28.Device manufacture date: 2021-02-09.Medical device lot #: 1074687.Medical device expiration date: 2022-03-31.Device manufacture date: 2021-03-15.Medical device lot #: 1137330.Medical device expiration date: 2022-05-31.Device manufacture date: 2021-05-17.Medical device lot #: 1165554.Medical device expiration date: 2022-06-30.Device manufacture date: 2021-06-14.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1014030.Medical device expiration date: 2022-01-31.Device manufacture date: 2021-01-14.Medical device lot #: 1040866.Medical device expiration date: 2022-02-28.Device manufacture date: 2021-02-09.Medical device lot #: 1074687.Medical device expiration date: 2022-03-31.Device manufacture date: 2021-03-15.Medical device lot #: 1137330.Medical device expiration date: 2022-05-31.Device manufacture date: 2021-05-17.Medical device lot #: 1165554.Medical device expiration date: 2022-06-30.Device manufacture date: 2021-06-14.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported when using the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg, the user complaint of the instruments clogging with micro-clots.The following information was provided by the initial reporter.The customer stated: "we had a call from our client and they have raised an issue with recently received 362799 tubes.Since around october last year (they've been using these bd tubes for years) they've noticed that their instruments started clogging with micro clots or fibrin.These formations are not visible to the naked eye, but they accumulate in the instrument needle and clog it in time.It¿s from one department where donors are tested, so first thing the personnel has been debriefed and received additional training to recap the correct blood collection with the emphasis on the inversions, even a shaker/rotator has been placed on site to mix the blood straight after collection, however nothing has changed.I am sending some pictures of the part showing the dirt.It definitely is fibrin, as they've asked pathology lab to investigate it and they confirmed this was fibrin.Nothing can be seen with a naked eye in the tubes after centrifugation before analysis.Sometimes they can see a film of some fatty substance on top of plasma, but it happens very rarely and they remove it before analysis." bd (b)(4) asked if the clots are present when they receive the samples in the lab or if they appear during analysis in the instrument and this is the reply we got: "here is the comment from the engineer: the part is ¿vacuum manifold¿.This part is connected to 10 hoses from two magwash washing stations (five hoses from each station) and a waste hose coming from a liquid waste tank.There is always a vacuum in the liquid waste tank, vacuum manifold, and magwash station probes.Mtu tubes are washed at the magwash station.Unnecessary test substance is removed during washing.Magwash reagent is added to the tube for washing, and the descending probes (because of the negative pressure in them) aspirate the liquid.The liquid travels to the vacuum manifold, and from it the thick waste hose travels to the liquid waste container.".
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Event Description
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It was reported when using the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg, the user complaint of the instruments clogging with micro-clots.The following information was provided by the initial reporter.The customer stated: "we had a call from our client and they have raised an issue with recently received 362799 tubes.Since around october last year (they¿ve been using these bd tubes for years) they¿ve noticed that their instruments started clogging with micro clots or fibrin.These formations are not visible to the naked eye, but they accumulate in the instrument needle and clog it in time.It¿s from one department where donors are tested, so first thing the personnel has been debriefed and received additional training to recap the correct blood collection with the emphasis on the inversions, even a shaker/rotator has been placed on site to mix the blood straight after collection, however nothing has changed.I am sending some pictures of the part showing the dirt.It definitely is fibrin, as they¿ve asked pathology lab to investigate it and they confirmed this was fibrin.Nothing can be seen with a naked eye in the tubes after centrifugation before analysis.Sometimes they can see a film of some fatty substance on top of plasma, but it happens very rarely and they remove it before analysis.".Bd nordic asked if the clots are present when they receive the samples in the lab or if they appear during analysis in the instrument and this is the reply we got: "here is the comment from the engineer: the part is ¿vacuum manifold¿.This part is connected to 10 hoses from two magwash washing stations (five hoses from each station) and a waste hose coming from a liquid waste tank.There is always a vacuum in the liquid waste tank, vacuum manifold, and magwash station probes.Mtu tubes are washed at the magwash station.Unnecessary test substance is removed during washing.Magwash reagent is added to the tube for washing, and the descending probes (because of the negative pressure in them) aspirate the liquid.The liquid travels to the vacuum manifold, and from it the thick waste hose travels to the liquid waste container.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 02-mar-2022.H6: investigation summary.Bd received 30 samples and 3 photos for investigation.The photos were reviewed and the indicated failure mode for clogged instrumentation and fibrin was not observed.Additionally, the customer samples were evaluated along with retention samples of the incident lot selected from bd inventory.The samples were tested and no issues relating to clogged instrumentation and fibrin were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to confirm the customer¿s indicated failure (fibrin/micro clots) because the defect was not evident in the testing of the complaint lot samples.Laboratory analysis of a combination of retain and customer (including control samples), demonstrated clinically acceptable performance for all visual observations evaluated.All tubes performed as expected.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode clogged instrumentation and fibrin.Bd was not able to identify a root cause for the indicated failure mode.Factors that may contribute to clogged instrumentation and fibrin were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.
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