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

Catalog Number 300865

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/31/2018

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 #: 1711281, medical device expiration date: 10/31/2022, device manufacture date: 11/30/2017.Medical device lot #: 1709230, medical device expiration date: 08/31/2022, device manufacture date: 09/11/2017.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 that the rubber stopper of the bd plastipak¿ concentric luer lock syringe was detached.It is unclear when the findings occurred.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: as no samples were returned for the reported issue, a sample investigation could not be completed.A device history record review for the provided lot numbers, 1711281 and 1709230, did not reveal any deviations or issues during production that could have contributed to the reported defect.Final products of lots 1711281 and 1709230 were sampled and subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the limited investigation, a cause for the reported issue could not be determined.Since the alleged defect cannot be confirmed, it has been determined no formal capa is required at this time.

Event Description

It was reported that the rubber stopper of the bd plastipak¿ concentric luer lock syringe was detached.It is unclear when the findings occurred.No reports of serious injury or medical intervention noted.

• Brand Name: BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7630110
• MDR Text Key: 112312162
• Report Number: 3003152976-2018-00246
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: SEE H.10.
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other