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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 309659
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/03/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.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¿ slip-tip disposable tuberculin syringe had foreign matter.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 309659 batch no: 9007849.It was reported that the product inside the syringe looked cloudy.Event description per customer's attached email states, "product inside syringe looks cloudy".
 
Manufacturer Narrative
H.6.Investigation: one resealed shelf carton was received, containing 200 sealed packaged 1ml s/t syringes from batch #9007849 (p/n 309659).The syringes were visually evaluated.37 out of 200 were found to have cloudy tips.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Cloudy tips are a result of normal molding process.Over time a small amount of plastic build up or residue occurs in the mold causing this defect.It is remedied by polishing the mold.The cloudy tip defect is cosmetic and does not pose risk to the customer.
 
Event Description
It was reported that bd¿ slip-tip disposable tuberculin syringe had foreign matter.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 309659 batch no: 9007849.It was reported that the product inside the syringe looked cloudy.Event description per customer's attached email states, "product inside syringe looks cloudy".
 
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Brand Name
BD SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key8527317
MDR Text Key142496411
Report Number1213809-2019-00454
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096597
UDI-Public30382903096597
Combination Product (y/n)N
PMA/PMN Number
K980580
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2023
Device Catalogue Number309659
Device Lot Number9007849
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2019
Date Manufacturer Received04/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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