MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ STERILE LUER SLIP SYRINGE

Catalog Number 303172

Device Problem Device Packaging Compromised (2916)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1610001p, medical device expiration date: 2021-09-30, device manufacture date: 2016-10-04.Medical device lot #: 1604010p, medical device expiration date: 2021-03-31, device manufacture date: 2016-04-07.Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported before use of the bd plastipak¿ sterile luer slip syringe there was an issue with the package seal integrity.The consumer stated ¿there was an open blister.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation results: one video has been received by our quality team for investigation.Upon visualization of the video it can be verified that the blister of 1ml syringes ref.303172 is not completely sealed, it is sealed only in one extreme.It can also be observed that the syringe has been packaged with other devices in a secondary package.A device history record review found no non-conformances associated with this issue during production of these batches.During the primary packaging process, seal testing is done during a functional inspection according to procedure.On checking the results for both lots they were within specification limits.Final products in this manufacturing line, for this reference and lot size were sampled and they were subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the quality team's investigation, no issues were identified and the manufacturing record established that all production and quality processes were carried out normally, so the root cause of the alleged defect cannot be determined.Based on all the preventive measures and our stringent in¿process inspection plan, we are certain that this should be an isolated issue and any recurrence is unlikely based on the seal testing performed during the manufacturing process per lot and no quality notifications were opened related with sealing of reported batch.Based in severity and occurrence not formal capa is required according to internal procedure.

• Brand Name: BD PLASTIPAK¿ STERILE LUER SLIP SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7411166
• MDR Text Key: 105416551
• Report Number: 3003152976-2018-00140
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303172
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other