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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYRINGE 30ML LL TIP CONV PAK; PISTON SYRINGE
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYRINGE 30ML LL TIP CONV PAK; PISTON SYRINGE Back to Search Results
Catalog Number 305618
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
Event Type  malfunction  
Manufacturer Narrative
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 the syringe 30ml ll tip conv pak experienced packaging tears while opening leaving paper shards.The following information was provided by the initial reporter: material no: 305618, batch no: 0307723.Upon opening the sterile package, a big black piece of fuzz/cardboard fell off the top paper liner and fell into the container with the syringes.This is the 5th package of 30 ml syinges that we have found foreign debris.
 
Manufacturer Narrative
H6: investigation summary: a device history record review was completed by our quality engineer team for provided lot number 0307723.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.
 
Event Description
It was reported that the syringe 30ml ll tip conv pak experienced packaging tears while opening leaving paper shards.The following information was provided by the initial reporter: material no: 305618, batch no: 0307723.Upon opening the sterile package, a big black piece of fuzz/cardboard fell off the top paper liner and fell into the container with the syringes.This is the 5th package of 30 ml syinges that we have found foreign debris.
 
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Brand Name
SYRINGE 30ML LL TIP CONV PAK
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
MDR Report Key11681731
MDR Text Key250451956
Report Number9610847-2021-00156
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/22/2021
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 Number305618
Device Lot Number0307723
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/19/2021
Initial Date FDA Received04/16/2021
Supplement Dates Manufacturer Received04/22/2021
Supplement Dates FDA Received05/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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