MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL 200 S/C; PISTON SYRINGE

Catalog Number 309657

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9099570.Medical device expiration date: 2024-03-31.Device manufacture date: 2019-04-20.Medical device lot #: 9119697.Medical device expiration date: 2024-03-31.Device manufacture date: 2019-05-05.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 one syringe 3ml ll 200 s/c has been found experiencing leakage during use.The following has been provided by the initial reporter: material no: 309657 batch no: unknown (9099570 or 9119697).It was reported that syringes leaked chemo meds.Per customer phone call on (b)(6) 2019, customer stated that incident occurred with 1 syringe.Customer couldn't confirm which lot number.There was no patient contact.Description: syringe leaked chemo meds, bd syringe luer lock tip 3cc lot number: l: 9099570, l: 9119697.

Event Description

It has been reported that one syringe 3ml ll 200 s/c has been found experiencing leakage during use.The following has been provided by the initial reporter: material no: 309657 batch no: unknown (9099570 or 9119697).It was reported that syringes leaked chemo meds.Per customer phone call on 9/11/2019, customer stated that incident occurred with 1 syringe.Customer couldn't confirm which lot number.There was no patient contact.Description: syringe leaked chemo meds, bd syringe luer lock tip 3cc lot number: l: 9099570 l: 9119697.

Manufacturer Narrative

H.6.Investigation: ten 3ml syringes in fully sealed blister packs (p/n 309657) were received and evaluated.Five were confirmed to be from batch 9119697 and five were confirmed to be from batch 9099570.The syringes were disassembled, and each component was visually examined under 10x magnification.No visual defects were observed.Prior to the visual examination, the received syringes were tested for leakage past stopper and leakage at luer per procedure.No syringes leaked at the luer.Two syringes from batch 9099570 leaked past the first rib of the stopper and one syringe from batch 9119697 leaked past the first rib of the stopper.Dimensional testing was performed on the syringe components with observed leakage.All barrels and plunger rods were acceptable per product specifications.Afterwards, the syringes were reassembled and retested for leakage past stopper with no leakage observed.Potential root cause for the leakage past stopper defect is undetermined.A thorough visual examination was performed in addition to dimensional testing of the syringes with no indication of defects.A device history record review showed no rejected inspections or quality issues during the production of the two provided lot number that could have contributed to the reported defect.

• Brand Name: SYRINGE 3ML LL 200 S/C
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9118561
• MDR Text Key: 194370079
• Report Number: 1213809-2019-00968
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309657
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other