MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL W/NDL 20X1 RB; PISTON SYRINGE

Catalog Number 309644

Device Problem Leak/Splash (1354)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: two photos and two loose 10ml syringes with attached needles (p/n 309644) were received.The samples were visually evaluated.Both sample's hubs were twisted nearly to the point of snapping.Each hub was twisted in the same location.The observed condition was non-conforming per product specification.Batch #0265079 is considered in compliance with our product specification requirements.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: potential root cause for the twisted hub defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Rationale: capa not required at this time.

Event Description

It was reported that syringe 10ml ll w/ndl 20x1 rb needle was damaged.The following information was provided by the initial reporter: it was reported that needle bent and stuck staff member while attempting to draw up medication.Customer response: did the staff member require any medical intervention? no.What was the date of the event? on (b)(6) 2021.

• Brand Name: SYRINGE 10ML LL W/NDL 20X1 RB
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12194014
• MDR Text Key: 262471229
• Report Number: 1213809-2021-00497
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096442
• UDI-Public: 00382903096442
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• 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
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309644
• Device Lot Number: 0265079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2020
• 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