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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1ML 26GA 12.7MM 10BAG 500CAS S-Q; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE SYRINGE 1ML 26GA 12.7MM 10BAG 500CAS S-Q; PISTON SYRINGE Back to Search Results
Catalog Number 305501
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 01/12/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the syringe 1ml 26ga 12.7mm 10bag 500cas s-q packaging seal was "weak" and had come loose.The following information was provided by the initial reporter, translated from spanish to english: "we have found that the sachets containing these syringes are poorly sealed." in some, the seal is very weak, and it is open or almost open.In others, it has a double seal, the first has come loose, but there is another heat seal that is very close to the edge.Photo 4 is a well-closed unit: it has a double seal, and although the lower one has been opened, the last heat seal (more on the edge) is complete.
 
Manufacturer Narrative
H6: investigation summary.Customer returned photos of poly bags of 1ml, 12.7mm, 26g plastipak sub-q syringes.Customer states that the sachets are poorly sealed.Photos were examined and exhibited the poly bags with an open seal along the top of the poly bag.A review of the device history record was completed for batch# 9343837.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.
 
Event Description
It was reported that the syringe 1ml 26ga 12.7mm 10bag 500cas s-q packaging seal was "weak" and had come loose.The following information was provided by the initial reporter, translated from spanish to english: "we have found that the sachets containing these syringes are poorly sealed." in some, the seal is very weak, and it is open or almost open.In others, it has a double seal, the first has come loose, but there is another heat seal that is very close to the edge.Photo 4 is a well-closed unit: it has a double seal, and although the lower one has been opened, the last heat seal (more on the edge) is complete.
 
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Brand Name
SYRINGE 1ML 26GA 12.7MM 10BAG 500CAS S-Q
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key11312173
MDR Text Key231398149
Report Number1920898-2021-00180
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 02/17/2021
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 Number305501
Device Lot Number9343837
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/18/2021
Initial Date FDA Received02/11/2021
Supplement Dates Manufacturer Received02/17/2021
Supplement Dates FDA Received02/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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