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

Catalog Number 302995

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2023

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 2 of the bd luer-lok¿ syringe sterile, single misaligned.The following information was provided by the initial reporter: there isn't a full seal on the syringe so when you place a butterfly on and try to pull back the rubber plunger tilts/twists loosing any vacuum and therefore all we get are bubbles.We have been having problems with the suction of the syringes.The rubber insert tilts and we are not getting a full seal.While drawing we just get bubbles along with small amount of blood.

Manufacturer Narrative

H6: investigation summary: twenty-five samples and one photo were provided to our quality team for investigation.All samples were tested, and all were found to be acceptable per product specification.Upon examination of the returned photo, it was observed that 10ml syringe have insecure stopper with the fluid past the stopper.Potential root cause for the insecure stopper defect is associated with the assembly process.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.H3 other text : see h10.

Event Description

It was reported that 2 of the bd luer-lok¿ syringe sterile, single misaligned.The following information was provided by the initial reporter: there isn't a full seal on the syringe so when you place a butterfly on and try to pull back the rubber plunger tilts/twists loosing any vacuum and therefore all we get are bubbles.We have been having problems with the suction of the syringes.The rubber insert tilts and we are not getting a full seal.While drawing we just get bubbles along with small amount of blood.

• 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
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16903475
• MDR Text Key: 314923234
• Report Number: 1213809-2023-00483
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903029952
• UDI-Public: 00382903029952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302995
• Device Lot Number: 3013528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 06/07/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1