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

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.

• 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 Key: 10043258
• MDR Text Key: 194175282
• Report Number: 3003916417-2020-00140
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• 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 Date: 08/31/2024
• Device Catalogue Number: 990256
• Device Lot Number: 9247261
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 05/11/2020
• Supplement Dates Manufacturer Received: 04/17/2020
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention