MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECCENTRIC TIP SYRINGE WITH PRECISIONGLIDE NEEDLE; SYRINGE WITH NEEDLE

Catalog Number 302147

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd eccentric tip syringe with precisionglide¿ needle had foreign matter in the barrel before use.This occurred on 3 separate occasions.The following information was provided by the initial reporter: there is fluid in the barrel before use.

Event Description

It was reported that bd eccentric tip syringe with precisionglide¿ needle had foreign matter in the barrel before use.This occurred on 3 separate occasions.The following information was provided by the initial reporter: there is fluid in the barrel before use.

Manufacturer Narrative

H.6.Investigation: photo evaluation: ¿ 1 photo was returned for evaluation.From the photo, observed a liquid inside the syringe barrel and tip.From the photo the liquid inside the syringe barrel and tip suspected silicone which was only liquid material spray on syringe barrel in syringe assembly process.The complaint is confirmed and product is out of specification.Based on the machine history recorded, there was replacement of silicon gun #5 & #8 due to silicone content result showed at minimum side.The possible root cause could due to the dispensing timer not adjusted or calibrated after replacement of silicon gun.There was revised manufacturing setup specification for syringe assembly (b)(4) to perform calibration upon silicon begun change at the line on (b)(6) 2018.The reported batch produced on mfg date: (b)(6) 2018 before action taken.(b)(4) was initiated.

• Brand Name: BD ECCENTRIC TIP SYRINGE WITH PRECISIONGLIDE NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8573413
• MDR Text Key: 144982537
• Report Number: 8041187-2019-00340
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 302147
• Device Lot Number: 8326758
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 04/17/2019
• Supplement Dates FDA Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other