MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE; PISTON SYRINGE

Catalog Number 300865

Device Problem Leak/Splash (1354)

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

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.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 during use leakage occurred with a bd plastipak¿ 50ml concentric luer lock syringe.The following information was provided by the initial reporter, translated from french to english: leakage with a drug under test, reconstituted under isolator, during sampling.The syringe was used properly for the first time, with a large leak via the piston resulting in product loss and environmental contamination.

Event Description

It was reported that during use leakage occurred with a bd plastipak¿ 50ml concentric luer lock syringe.The following information was provided by the initial reporter, translated from french to english: leakage with a drug under test, reconstituted under isolator, during sampling.The syringe was used properly for the first time, with a large leak via the piston resulting in product loss and environmental contamination.

Manufacturer Narrative

Investigation: one photo sample was provided to our quality team for investigation.Upon visually inspecting the photo, a leakage past the stopper was observed.A device history review was performed for the reported lot 1907257, no deviations or non-conformance's were identified during the manufacturing process that could have contributed to this issue.Ten retained samples of lot 1907257 were used to conduct a leakage test.The product was visually inspected, no defects or damage was noted that could contribute to a leak, and no leakage was identified.Based on the available information we are not able to determine a root cause at this time.

• Brand Name: BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9526720
• MDR Text Key: 204450271
• Report Number: 3003152976-2019-00885
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: 1907257
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other