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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 5ML LS 23GA 1-1/4IN TW; PISTON SYRINGE
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BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 5ML LS 23GA 1-1/4IN TW; PISTON SYRINGE Back to Search Results
Catalog Number 302131
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 syringe 5ml ls 23ga 1-1/4in tw packaging was damaged.This occurred on 100 occasions.The following information was provided by the initial reporter: the empty needle is exposed in the integrated packaging.
 
Manufacturer Narrative
H.6.Investigation: two photos were received by our quality team for evaluation.From the photos, the individual blister package was observed to be torn with no sealing area peel off.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.From the photos, the team was not ablet to confirm if there were any difficulties in perforation or crosscut cutting line which resulted in the package being torn.The primary and secondary packaging processes were reviewed.The team was unable to identify any contact points that could result in the package being torn onto the top web and bottom web during operation.As no sample was returned for further analysis, the root cause could not be determined.
 
Event Description
It was reported that syringe 5ml ls 23ga 1-1/4in tw packaging was damaged.This occurred on 100 occasions.The following information was provided by the initial reporter: the empty needle is exposed in the integrated packaging.
 
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Brand Name
SYRINGE 5ML LS 23GA 1-1/4IN TW
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key12207343
MDR Text Key263433256
Report Number8041187-2021-00624
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
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 08/10/2021
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 Number302131
Device Lot Number1014619
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/22/2021
Initial Date FDA Received07/21/2021
Supplement Dates Manufacturer Received08/10/2021
Supplement Dates FDA Received08/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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