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

Catalog Number 301947

Device Problem Packaging Problem (3007)

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

Event Date 02/07/2023

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 prior to use with bd¿ syringe with needle the unit package was discovered to be damaged thus affecting its sterility.The following information was provided by the initial reporter, translated from japanese to english: when preparing to treat the child, it was found that the outer packaging of the disposable sterile syringe leaked air, and the new syringe was replaced in time, and the child was not affected.

Manufacturer Narrative

A device history record review was completed for provided material number 301947 and lot number 2105245.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 evaluation.None of the retained samples displayed any signs of defect and the sealing area of the samples were found to be within perfect condition.No holes were observed in the top or bottom web of the syringe packaging.H3 other text : see h10.

Event Description

It was reported that prior to use with bd¿ syringe with needle the unit package was discovered to be damaged thus affecting its sterility.The following information was provided by the initial reporter, translated from japanese to english: when preparing to treat the child, it was found that the outer packaging of the disposable sterile syringe leaked air, and the new syringe was replaced in time, and the child was not affected.

• Brand Name: BD¿ SYRINGE WITH NEEDLE
• 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: 16492966
• MDR Text Key: 311412084
• Report Number: 3002682307-2023-00041
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903019472
• UDI-Public: (01)00382903019472
• 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: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301947
• Device Lot Number: 2105245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2021
• 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