MAUDE Adverse Event Report: BECTON DICKINSON BD 2 PC 5 ML SYRINGE - DISCARDIT II 22G×1; PISTON SYRINGE

Catalog Number 301285

Device Problems Leak/Splash (1354); Physical Resistance/Sticking (4012)

Patient Problem Pain (1994)

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is bawal.This site is an oem manufacturing site.(b)(4).Investigation summary the two photos were received by bd for evaluation.A quality engineer was able to review the photo of a discarditii 5ml with 22x1 from lot number 2256766 regarding item number 301285 with the reported issue of plunger movement difficult and leakage.As there is photograph available of unused syringe, the reported defect cannot be confirmed.The investigation and simulation were carried out on the retention samples.During investigation, no tightness in plunger or leakage in syringe was observed in retention samples of lot number 2256766 regarding item number 301285.No further action could be taken as defect cannot be confirmed by photographs available and no tightness or leakage observed during investigation of the complaint.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

Event Description

It was reported while using bd 2 pc 5 ml syringe - discardit ii 22g×1 the plunger was difficult to move and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: stiff plunger movement.Blood leaking out during blood withdraw.

• Brand Name: BD 2 PC 5 ML SYRINGE - DISCARDIT II 22G×1
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16462123
• MDR Text Key: 310676445
• Report Number: 2243072-2023-00279
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903012855
• UDI-Public: (01)00382903012855
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 02/07/2023

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: 301285
• Device Lot Number: 2256766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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