MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD TWINPAK; SYRINGE 10ML LL W/TWINPAK DEVICE

Catalog Number 303393

Device Problem Break (1069)

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

Event Date 01/19/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that the bd twinpak needles are defective.The following information was provided by the initial reporter: "we have been having a lot of trouble with our 10ml syringe item#303393 (ref#(b)(4)).I have attached pictures.The needle portion keeps breaking off, or is broken off.It appears to be the same lot (#3060712) that is having this issue.Just wondering if others are reporting this issue or if you know of a recall on this lot?".

Manufacturer Narrative

Three samples and four photos of 10ml twin-pack syringes lot 3060712 were received and evaluated.Two of the samples were received in sealed packages and one in an unsealed package.All three samples have the needle broken at the red hub.Two of the photos show the top web portion of the web with one showing a close-up image of the batch #.The other two photos show the needle broken inside the sealed package, with one image showing all 3 samples, and the other a closeup image of the needle area.The condition observed is non-conforming per product specification.Potential root cause for the needle broken defect is associated with the assembly process.Most likely cause is the needle was over-torqued when applied to the syringe.A device history record review was completed for provided lot number 3060712 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

Material#: 303393.Lot#: 3060712.It was reported by the customer that the needle portion keeps breaking off.Verbatim: rcc received a complaint via email.We have been having a lot of trouble with our 10ml syringe item#303393 (ref#(b)(4).I have attached pictures.The needle portion keeps breaking off, or is broken off.It appears to be the same lot (#3060712) that is having this issue.Just wondering if others are reporting this issue or if you know of a recall on this lot?.

• Brand Name: BD TWINPAK
• Type of Device: SYRINGE 10ML LL W/TWINPAK DEVICE
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18707367
• MDR Text Key: 336416483
• Report Number: 1213809-2024-00082
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K974006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2024

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: 303393
• Device Lot Number: 3060712
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1