MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SOLOMED¿ SYRINGE; PISTON SYRINGE

Catalog Number 302772

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2023

Event Type  malfunction  

Event Description

It was reported that 2 bd solomed¿ syringes' hubs were skewed/damaged.The following information was provided by the initial reporter, translated from chinese: "the dealer reported that the packaging of the sealed syringe was found to be skewed at the junction between the metal part of the needle and the plastic.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary a device history record review was completed for provided material number 302772 and lot number 2110403.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty (20) retained samples were obtained from the manufacturing facility for review.However, the retained samples did not display any signs of defect.Based on the investigation results, we were unable to identify a manufacturing related cause for this reported incident.

Event Description

It was reported that 2 bd solomed¿ syringes' hubs were skewed/damaged.The following information was provided by the initial reporter, translated from chinese: "the dealer reported that.The packaging of the sealed syringe was found to be skewed at the junction between the metal part of the needle and the plastic.".

• Brand Name: BD SOLOMED¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16522314
• MDR Text Key: 311413509
• Report Number: 3002682307-2023-00049
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

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 Number: 302772
• Device Lot Number: 2110403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1