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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK 1ML INSULIN SYRINGE; PISTON SYRINGE

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BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK 1ML INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 990256
Device Problems Device Markings/Labelling Problem (2911); Packaging Problem (3007)
Patient Problem Needle Stick/Puncture (2462)
Event Date 04/17/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).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 prior to use needle was attached to a syringe different than what package described and employee was punctured.Needle was also outside of the sterile packaging with a bd plastipak¿ 1ml insulin syringe.The following information was provided by the initial reporter, translated from portuguese to english: when opening the syringe box, it was punctured the finger in a needle that was attached to a syringe different from the described in the package.
 
Event Description
It was reported that prior to use needle was attached to a syringe different than what package described and employee was punctured.Needle was also outside of the sterile packaging with a bd plastipak¿ 1ml insulin syringe.The following information was provided by the initial reporter, translated from portuguese to english: when opening the syringe box, it was punctured the finger in a needle that was attached to a syringe different from the described in the package.
 
Manufacturer Narrative
H.6.Investigation: it was performed the dhr, maintenance record analysis and quality notification analysis and no deviation were found for this batch.Photos were sent by the customer and it was possible to observe syringe mix, with needle.This mix lead to the needle stick and blister opened.According the evaluation of batch history the cause for the occurrence is a operational failure during line setup and line clearance, the previous catalog was a syringe with needle and one syringe was packaged at syringe without needle batch.The line operators will be notified about this complaint and will receive additional training about line clearance procedure.H3 other text : see h.10.
 
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Brand Name
BD PLASTIPAK 1ML INSULIN SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
MDR Report Key10043258
MDR Text Key194175282
Report Number3003916417-2020-00140
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2024
Device Catalogue Number990256
Device Lot Number9247261
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/17/2020
Initial Date FDA Received05/11/2020
Supplement Dates Manufacturer Received04/17/2020
Supplement Dates FDA Received05/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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