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

Catalog Number 300865

Device Problem Fungus in Device Environment (2316)

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

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

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 product smelled moldy with a bd plastipak¿ 50 ml concentric luer lock syringe.The following information was provided by the initial reporter: one of the end-users contacted distributor about their plastipak, smelled bad, moldy, odor.The end user wanted another package with fresh plastipak.The distributor went to where the plastipaks are placed.But they were also smelling bad (moldy, odor).They have 5520 pieces (92 boxes) that they now want to discard.

Manufacturer Narrative

Additional information d.10 device available for eval yes, returned to manufacturer on: 2020-03-30 h.6.Investigation summary one closed box with sixty samples were provided to our quality team for investigation.The box was visually inspected, no humidity was observed on the cardboard, there were no drops of water identified outside the syringe containers, and no odor was detected.A device history review was performed for reported lot 1912289, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.We have reviewed the sterilization cycle and inspections for this lot and found all results met required specifications.There have been no changes in the manufacturing process or materials used to manufacture this product.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based upon the visual inspection of the samples received and the quality team's investigation, we were unable to determine the root cause for the alleged defect at this time.Complaints received for this defect and device will be monitored by our quality team for future occurrences.

Event Description

It was reported that the product smelled moldy with a bd plastipak¿ 50ml concentric luer lock syringe.The following information was provided by the initial reporter: one of the end-users contacted distributor about their plastipak, smelled bad, moldy-odor.The end-user wanted another package with fresh plastipak.The distributor went to where the plastipaks are placed.But they were also smelling bad (moldy-odor).They have 5520 pieces (92 boxes) that they now want to discard.

• 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: 9928950
• MDR Text Key: 205685842
• Report Number: 3003152976-2020-00154
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: 1912289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other