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

Model Number 309657

Device Problem Leak/Splash (1354)

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

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Initial reporter facility name: (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that an unspecified number of syringes 3ml ll 200 s/c experienced leakage at the connection site during use.The following information was provided by the initial reporter: material no.: 309657 batch no.: unknown.Complaint 4 of 4 possible lots: 9225551, 1257026, 8318741, 8297832, 9186751.**the customer pulled 5 bd 3ml syringes from their supply room as only one was saved and they wanted to bd to have a mix of lot numbers to test.It was reported the 3ml syringes appear to leak when connected to a bd maxzero needleless connector.Verbatim: nicu manager at user facility said the continued incidents their nicu has been having with what appears to be leaking from bd 3ml syringes when connected to a bd maxzero needleless connector.It is believed that the leaking has been happening more frequently than the reported events based on her recent conversations with her nurses.This may also be happening with bd 1ml syringes.Health professional wasn't 100% sure, but would like us to test 1ml syringes if possible.

Manufacturer Narrative

H.6.Investigation: no samples or photos received for investigation.The lot number 1257026 is expired, the manufacturing plant is unable to verify.Therefore device history record review (dhr) or quality notification review (qn) could not be performed.For lot number 8318741,8297832, during the documentary review, no quality notifications were found that could cause the defect reported by the client, the lot was inspected and approved in accordance with the established quality guidelines.Capa#1132752 is currently under investigation, with which it is sought to identify possible failure modes that cause the defect, as well as possible improvements, likewise, it should be noted that the lot was manufactured prior to the closure of the capa h3 other text : see h.10.

Event Description

It was reported that an unspecified number of syringes 3ml ll 200 s/c experienced leakage at the connection site during use.The following information was provided by the initial reporter: material no.: 309657, batch no.: unknown.Complaint 4 of 4.Possible lots: 9225551, 1257026, 8318741, 8297832, 9186751.The customer pulled 5 bd 3ml syringes from their supply room as only one was saved and they wanted to bd to have a mix of lot numbers to test.It was reported the 3ml syringes appear to leak when connected to a bd maxzero needleless connector.Verbatim: nicu manager at user facility said the continued incidents their nicu has been having with what appears to be leaking from bd 3ml syringes when connected to a bd maxzero needleless connector.It is believed that the leaking has been happening more frequently than the reported events based on her recent conversations with her nurses.This may also be happening with bd 1ml syringes.Health professional wasn't 100% sure, but would like us to test 1ml syringes if possible.

• 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: 9527357
• MDR Text Key: 190482707
• Report Number: 1213809-2019-01313
• 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: health professional,other,use
• 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: 309657
• Device Catalogue Number: 309657
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• 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