MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SOLOMED SYRINGE; PISTON SYRINGE

Catalog Number 302633

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/30/2020

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that the bd solomed syringe was missing the protective shield in the sealed packaging.The following information was provided by the initial reporter, translated from (b)(6) to english: "pharmacist got in touch to report that when handling the material for sale at the pharmacy, he pierced his hand, the material did not have the protective shield and was sealed in the original factory packaging.Asked if there was any other material with the same deviation, however, it was only this material that had presented the deviation.Material had not been used.".

Manufacturer Narrative

H6: investigation summary it was performed the dhr, quality notifications and maintenance records were checked where no records potentially related to failure were found.The available image was analyzed and it was possible to confirm the defect absence of the needle protector.A possible cause for the problem is a failure in the machine's mounting system that due to vibration caused the absence of the protector.The defect identified from this complaint will be monitored for trend evaluation.See h.10.

Event Description

It was reported that the bd solomed¿ syringe was missing the protective shield in the sealed packaging.The following information was provided by the initial reporter, translated from portuguese to english: "pharmacist got in touch to report that when handling the material for sale at the pharmacy, he pierced his hand, the material did not have the protective shield and was sealed in the original factory packaging.Asked if there was any other material with the same deviation, however, it was only this material that had presented the deviation.Material had not been used.".

• Brand Name: BD SOLOMED SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 11091352
• MDR Text Key: 225807746
• Report Number: 3003916417-2020-00374
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 302633
• Device Lot Number: 0195098
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1