MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML S/T W/NDL 27X1/2 RB; PISTON SYRINGE

Catalog Number 309623

Device Problem Leak/Splash (1354)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: two 1ml syringes with needle (p/n 309623) were received in packages from batch #1042354.One package was received partially open, and one was completely sealed.Both syringes had no visible defects present.The syringe in the sealed package that had not been manipulated was tested for shield removal force and yielded acceptable results per product specification.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: since no samples displaying the reported condition were received a potential root cause could not be defined.Rationale: capa not required at this time.

Event Description

It was reported that syringe 1ml s/t w/ndl 27x1/2 rb separates from the needle.This occurred on 4 occasions.The following information was provided by the initial reporter: it was reported by the sales representative that the cap is loose on the syringe upon opening the packaging, the needle pulls off of the syringe, and needle stick to user.It was found that when taking the syringe out of the packaging, it is first needed to 'push' the cap onto the syringe tight.When doing this, the cap then will pull off and leave the needle on the syringe.If the cap is not pushed tightly onto the syringe before pulling the cap off, the needle will come off with the cap.

• Brand Name: SYRINGE 1ML S/T W/NDL 27X1/2 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: 12096534
• MDR Text Key: 264500284
• Report Number: 1213809-2021-00462
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096237
• UDI-Public: 00382903096237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980580
• 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: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309623
• Device Lot Number: 1042354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• 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