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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 21X1 RB TW; PISTON SYRINGE
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BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 21X1 RB TW; PISTON SYRINGE Back to Search Results
Catalog Number 305764
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/05/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that after "bicillin la" was administered with the needle eclipse 21x1 rb tw, the safety shield broke off when attempting to cover the needle.The following information was provided by the initial reporter: the site is in receipt of a marked product complaint identifying a needle that was supplied was dull.The user reported that the needle was more difficult to push through.The customer stated that the bicillin la was administered successfully and no complications occurred.The customer also stated that the safety shield broke off when closing.Bd eclipse needle 21 gauge 1" (vendor lot: 7176188) were used to package bicillin la 1ml batch w0783.
 
Manufacturer Narrative
H.6.Investigation: a review of past 12 months quality notification were performed and no quality notification was raised on the reported defects.The reported defects cannot be confirmed as no photo / samples were returned for investigation.Therefore, root cause could not be determined.
 
Event Description
It was reported that after "bicillin la" was administered with the needle eclipse 21x1 rb tw, the safety shield broke off when attempting to cover the needle.The following information was provided by the initial reporter: the site is in receipt of a marked product complaint identifying a needle that was supplied was dull.The user reported that the needle was more difficult to push through.The customer stated that the bicillin la was administered successfully and no complications occurred.The customer also stated that the safety shield broke off when closing.Bd eclipse needle 21 gauge 1" (vendor lot: 7176188) were used to package bicillin la 1ml batch w0783.
 
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Brand Name
NEEDLE ECLIPSE 21X1 RB TW
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key8539880
MDR Text Key145118912
Report Number8041187-2019-00315
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903057642
UDI-Public30382903057642
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 05/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2022
Device Catalogue Number305764
Device Lot Number7176188
Was Device Available for Evaluation? No
Date Manufacturer Received04/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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