MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRASAFE PLUS X100L PR WHITE CCL; ANTISTICK SYRINGE

Catalog Number 47443402

Device Problem Defective Component (2292)

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

Event Date 08/15/2023

Event Type  malfunction  

Event Description

It was reported while using bd ultrasafe plus x100l pr white ccl the plunger rod bent during use.There was no report of patient impact.The following information was provided by the initial reporter: per subject, syringe was intact upon removal from the ip container.However when she went to administer the drug, the plunger bent and then fell out of the device.Subject then placed the broken ip device into the ip container.They had not dropped or damaged the box in any way and the other three needles worked as intended.The subject report on (b)(6) 2023 and retrained subject to report any subsequent events to the site immediately.

Manufacturer Narrative

H.6 investigation summary: unconfirmed: bd could not confirm the reported condition.Bdm-ps performed an electronic batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batch involved in this complaint meets all acceptable quality levels (aql¿s), was manufactured, and released according to applicable procedures and specifications.

• Brand Name: BD ULTRASAFE PLUS X100L PR WHITE CCL
• Type of Device: ANTISTICK 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17795401
• MDR Text Key: 324027887
• Report Number: 2243072-2023-01696
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 47443402
• Device Lot Number: 14930739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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