MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML LL W/O DN; PISTON SYRINGE

Model Number 309628

Device Problem Leak/Splash (1354)

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

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the bd¿ syringe 1ml ll w/o dn has been found experiencing two occurrences of broken plunger rods during use.The following has been provided by the initial reporter: two chemotherapy preparations with syringe, syringe plunger breaks and leakage of the product.Re-fabrication.

Manufacturer Narrative

H.6 investigation summary: one opened empty package and two sealed packaged 1ml ll syringes were received.All packages were confirmed to be from batch #9170678 (p/n 309628).The samples were visually evaluated.No defects were observed with the empty package as it contained no sample.The two syringes were observed to have intact plunger rods.The plunger rods were pulled out and evaluated.No cracks or damage was observed.No defects were found with the returned samples.It is not entirely clear what the failure was since no photos were provided for reference.The reported defect was not identified in the samples received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It has been reported that the bd¿ syringe 1ml ll w/o dn has been found experiencing two occurrences of broken plunger rods during use.The following has been provided by the initial reporter: two chemotherapy preparations with syringe, syringe plunger breaks and leakage of the product.Re-fabrication.

• Brand Name: BD SYRINGE 1ML LL W/O DN
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9521635
• MDR Text Key: 193653335
• Report Number: 1213809-2019-01307
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• PMA/PMN Number: K941562
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: 9170678
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other