BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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Model Number 367955 |
Device Problem
Device Ingredient or Reagent Problem (2910)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2022 |
Event Type
malfunction
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Event Description
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It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes has problems with dry gel tubes.The following information was provided by the initial reporter.The customer stated: "our technical platform in cahors victor hugo has also reported problems with dry gel tubes on the following lots: lots 2164897- 2145913- 2171047- 2125067.".
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.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 #: 2164897, medical device expiration date: 2023-12-31, device manufacture date:2022-06-13.Medical device lot #: 2145913, medical device expiration date: 2023-11-30, device manufacture date: 2022-05-25.Medical device lot #: 2171047, medical device expiration date: 2023-12-31, device manufacture date: 2022-06-20.Medical device lot #: 2125067, medical device expiration date: 2023-11-30, device manufacture date: 2022-05-05.
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Manufacturer Narrative
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Lot/batch #: 2164897, 2171047.Bd had not received samples, but 2 photo was provided for investigation.The photo was reviewed and the indicated failure mode for red cell hang up was observed.A complaint history review was performed and revealed a confirmed complaint trend for some sample quality issues including red cell hang-up.Based on the confirmed complaint trend a capa (corrective and preventive action) was initiated.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 has been confirmed for red cell hang up based on the trend identified and the photo provided.A corrective and preventive action was created to address the issue.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.Lot/batch #: 2145913, 2125067.Bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for red cell hang up was observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, the indicated failure mode for red cell hang up was not observed.There were no difficulties encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate the customer¿s indicated failure mode, red cell hang up, because the defect was not evident in the testing of the complaint lot samples.All visual observations of both retain and control samples tested demonstrated clinically acceptable performance.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 has been confirmed for the indicated failure mode red cell hang up based on photos only.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes has problems with dry gel tubes.The following information was provided by the initial reporter.The customer stated: "our technical platform in cahors victor hugo has also reported problems with dry gel tubes on the following lots: lots 2164897- 2145913- 2171047- 2125067.".
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