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

Catalog Number 300865

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 04/17/2022

Event Type  malfunction  

Event Description

It was reported while using bd plastipak¿ syringes leakage occurred from a hole.There was no report of patient impact.The following information was provided by the initial reporter: date of occurrence: (b)(6) 2022.Incident description: a department reported to us a leak of norepinephrine solution during syringe preparation.On visual inspection clearly shows that the body of the syringe was already damaged and that this syringe should have been immediately discarded.

Manufacturer Narrative

No photos or physical samples that display the reported condition were available for investigation.A device history review was performed for the reported lot 2201089, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures, no issues related to the reported incident were identified during manufacturing.Damage can occur due to the product jamming within manufacturing equipment.Without the sample to evaluate, we cannot verify this to be true for the incident reported.Based on the available information we cannot identify a root cause at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

• Brand Name: BD PLASTIPAK¿ SYRINGES
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14733675
• MDR Text Key: 294531361
• Report Number: 3003152976-2022-00274
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 06/01/2022

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: 300865
• Device Lot Number: 2201089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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