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

Catalog Number 301942

Device Problem Unsealed Device Packaging (1444)

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

Event Date 07/22/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 the bd slip-tip syringe with bd precisionglide¿ needle packaging was not properly sealed.The following information was provided by the initial reporter, translated from chinese: "when you want to use the product, you find that it does not seal properly.".

Manufacturer Narrative

A device history record review was completed for provided material number 301942 and lot number 2107217.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.Through examination of the retained samples, no signs of defect could be identified.Based on the provided feedback, it is possible that this incident resulted from the primary packaging machine.The unit packaging is sealed by pressure and temperature and both parameters are controlled by operators with in-process inspections performed.It is possible that the sealing tested with lower values that were still within specification; however, due to some issue during transport, the blister packages became easier to open.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD SLIP-TIP SYRINGE WITH BD PRECISIONGLIDE¿ 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17540859
• MDR Text Key: 321236122
• Report Number: 3002682307-2023-00249
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301942
• Device Lot Number: 2107217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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