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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ LUER-LOK¿ SYRINGE; PISTON SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ LUER-LOK¿ SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 301229
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2023
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 8 bd plastipak¿ luer-lok¿ syringe packaging units were found torn.The following information was provided by the initial reporter: "8pcs - torn"."shows the syringe packaging torn".
 
Event Description
It was reported that 8 bd plastipak¿ luer-lok¿ syringe packaging units were found torn.The following information was provided by the initial reporter: "8pcs - torn" "shows the syringe packaging torn".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 08-mar-2023.H6: investigation summary both photos and physical samples were provided to our quality team for investigation.The visual inspection, the paper portion of the packaging is observed to be torn and a particle can be seen in the sealing area of the packaging, verifying the reported incident.A device history review was performed for reported lot 2205120, while there was no non-conformances in relation to the particle, one annotation was found related to issues with the packaging machine.During the packaging process, issues were found related to damage to the film and paper portion of the package.Increased inspections were performed to detect any impacted product while actions were taken to correct the problem.
 
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Brand Name
BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16566974
MDR Text Key312018531
Report Number3003152976-2023-00077
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/05/2023
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 Number301229
Device Lot Number2205120
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/28/2023
Initial Date FDA Received03/17/2023
Supplement Dates Manufacturer Received04/05/2023
Supplement Dates FDA Received04/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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