MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE STERILE, SINGLE USE; PISTON SYRINGE

Catalog Number 309646

Device Problem Gas/Air Leak (2946)

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

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the bd luer-lok¿ syringe sterile, single use the "syringes are allowing air to enter the syringe when they pull back for blood draws while attached to butterfly." material no.: 309646.Batch/lot: 8337846.The following information was provided by the initial reporter: it was reported that the "syringes are allowing air to enter the syringe when they pull back for blood draws while attached to butterfly." customer text: bd 5 ml syringes are allowing air to enter the syringe when they pull back for blood draws while attached to butterfly.Customer performed the same procedure with the 10ml and 3ml and there were no issues.

Manufacturer Narrative

Investigation: one sealed shelf carton of 5ml syringes was received, confirmed to be from batch #8337846 (p/n 309646).The 125 syringes inside the shelf carton were visually evaluated.104 were found to have no defects, while 21 were observed to have minor tip damage on the edge of the tip.The damage observed was minor, visible only under magnification.All 125 samples were tested for leakage per procedure.All syringes passed with no leakage observed.The connection between the tip and needle was not compromised in any of the samples, therefore the minor damage observed is considered a cosmetic defect.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect.

Event Description

It was reported that during use of the bd luer-lok¿ syringe sterile, single use the "syringes are allowing air to enter the syringe when they pull back for blood draws while attached to butterfly." material no.: 309646.Batch/lot: 8337846.The following information was provided by the initial reporter: it was reported that the "syringes are allowing air to enter the syringe when they pull back for blood draws while attached to butterfly." customer text: bd 5 ml syringes are allowing air to enter the syringe when they pull back for blood draws while attached to butterfly.Customer performed the same procedure with the 10ml and 3ml and there were no issues.

• Brand Name: BD LUER-LOK SYRINGE STERILE, SINGLE USE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8506014
• MDR Text Key: 145003058
• Report Number: 1213809-2019-00431
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: 30382903096467
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 309646
• Device Lot Number: 8337846
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other