MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE¿ 10 ML LL BNS; PISTON SYRINGE

Catalog Number 301029

Device Problem Fracture (1260)

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

Event Date 12/22/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot#: 0071631, medical device expiration date: 28-feb-2025, device manufacture date: 11-mar-2020, medical device lot#: 0083097, medical device expiration date: 28-feb-2025, device manufacture date: 23-mar-2020, medical device lot#: 0127985, medical device expiration date: 30-apr-2025, device manufacture date: 06-may-2020, medical device lot#: 0090399, medical device expiration date: 31-mar-2025, device manufacture date: 30-mar-2020.

Event Description

It was reported that 320 of the bd syringe¿ 10 ml ll bns experienced (short description of event).The following information was provided by the initial reporter: as you can see by the pictures attached, some syringes are cracked on the body (barrel).

Event Description

It was reported that 320 of the bd syringe¿ 10 ml ll bns experienced (short description of event) the following information was provided by the initial reporter: as you can see by the pictures attached, some syringes are cracked on the body (barrel).

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 14-feb-2023.H6: investigation summary nine samples and two photos were provided to our quality team for investigation.A visual inspection was performed.Two samples were observed to have minor cosmetic scuffing inside and outside of the print area on the mid-point of the barrel.One sample was observed to have a snapped plunger thumb-rest.Six samples were observed to have one vertical crack extending up the barrel.Potential root cause for the cracked barrel and broken thumb-rest defects are associated with the assembly process.It could be possible that an inadvertent jam or improper transfer between assembly dials led to the condition observed.These defects are occurring at an expected rate so no corrective actions will be made at this time.A device history record review was completed for provided lot numbers 0071631, 0083097, 0127985 and 0090399.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.H3 other text : see h10.

• Brand Name: BD SYRINGE¿ 10 ML LL BNS
• 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 ; 8015296192
• MDR Report Key: 16150655
• MDR Text Key: 308861091
• Report Number: 1213809-2022-01378
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

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: 301029
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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