Catalog Number 42103E-07 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
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Event Description
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It was reported that the bd alaris¿ smartsite¿ gravity set packaging was found open and unsealed before use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "i do not feel confident this product will work for our system.After testing the case of 100 sets ¿ 14 were not clinically acceptable.12 sets ¿ pulled apart when right out of the package 1 set- kinked and likely not usable 1 set- package was opened and not sealed (not sure if that was done by xxxx prior to me getting the lot).This was noted before use.Was there any patient involvement? no, see previous answer.Any adverse events or serious injury reported to patient or healthcare professional? no, see previous answer.What was the patient outcome? n/a.Was there any delay of, or change in, the course of treatment due to this event? n/a.What procedure was being performed? n/a.What medication was used in the procedure? n/a.Was there any medical intervention due to this event? n/a.Are you able to reconfirm is ¿pulled apart when right out of the package¿ meant by separation of component but no leakage issue? yes.Are you able to reconfirm the ¿kinked and likely not usable¿ is tubing kinked? yes.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d4: medical device lot #: 22129213.D4: medical device expiration date: 13-dec-2025.H4: device manufacture date: 12-dec-2022.D10: device available for eval yes.D10: returned to manufacturer on: 08-aug-2023.H6: investigation summary: the customer reported that one sample had a packaging issue, and returned it along with the large box of samples.The issue could not be verified, as the box returned a huge pile of mostly opened samples.The samples were already opened to check for the separation by the time they were received for investigation.Device history record review for model 42103e-07 lot number 22129213 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause is unknown without an observed failure.
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Event Description
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It was reported that the bd alaris¿ smartsite¿ gravity set packaging was found open and unsealed before use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "i do not feel confident this product will work for our system.After testing the case of 100 sets ¿ 14 were not clinically acceptable." 12 sets ¿ pulled apart when right out of the package.1 set- kinked and likely not usable.1 set- package was opened and not sealed (not sure if that was done by xxxx prior to me getting the lot).This was noted before use: was there any patient involvement? no, see previous answer.Any adverse events or serious injury reported to patient or healthcare professional? no, see previous answer.What was the patient outcome? n/a.Was there any delay of, or change in, the course of treatment due to this event? n/a.What procedure was being performed? n/a.What medication was used in the procedure? n/a was there any medical intervention due to this event? n/a.Are you able to reconfirm is ¿pulled apart when right out of the package¿ meant by separation of component but no leakage issue? yes.Are you able to reconfirm the ¿kinked and likely not usable¿ is tubing kinked? yes.
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Search Alerts/Recalls
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