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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL (SINGAPORE) BD ECCENTRIC TIP SYRINGE WITH PRECISIONGLIDE NEEDLE; SYRINGE WITH NEEDLE Back to Search Results
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.
 
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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 Key8573413
MDR Text Key144982537
Report Number8041187-2019-00340
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K110771
Number of Events Reported1
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 Date11/30/2023
Device Catalogue Number302147
Device Lot Number8326758
Initial Date Manufacturer Received 04/17/2019
Initial Date FDA Received05/02/2019
Supplement Dates Manufacturer Received04/17/2019
Supplement Dates FDA Received05/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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