MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 302147

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd¿ syringe with precisionglide¿ needle the tip of the needle was damaged.The following information was provided by the initial reporter: the tip of syringe is slanting.

Manufacturer Narrative

H6: investigation: one photo and one sample were received by our quality team for evaluation.From the photo and sample, the tip was observed to be bent.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The team has investigated different sections of machine and matched a potential area which could lead to the bent syringe tip.This nonconformance could have occurred during the transition to the conveyor after the syringe needle assembly process.The probable root cause could be due to the syringe assembled needle being stuck in between the conveyor gap during the unloading station.This caused the needle to press against the barrel tip and resulted in the bent barrel tip.A permanent space has been fabricated to close the gap in the conveyor after the reported batch was produced.

Event Description

It was reported while using bd¿ syringe with precisionglide¿ needle the tip of the needle was damaged.The following information was provided by the initial reporter: the tip of syringe is slanting.

• Brand Name: BD¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13640475
• MDR Text Key: 286540106
• Report Number: 8041187-2022-00106
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 03/15/2022

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: 302147
• Device Lot Number: 0268118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2020
• 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