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

Catalog Number 300629

Device Problem Packaging Problem (3007)

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

Event Date 03/09/2023

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 480 of the bd plastipak¿ syringe package were open and had the letter p was written on it.The following information was provided by the initial reporter, translated from dutch to english: a nurse delivered us a syringe with the letter "p" written on it.This syringe came right out of the package so it was delivered that way.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 03-apr-2023.H6: investigation summary.One sample received for investigation.Upon visual evaluation, it can be observed a p written in the flange of the syringe.A device history review was performed for lot 2212041, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Silicone station for 20ll syringe has several siliconizers that are tested periodically to check if silicone that is being sprayed is correct.To differentiate the siliconizers, a p is written.Based on team investigation, possible root cause is associated with not following process during silicone verification.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.H3 other text : see h10.

Event Description

It was reported that 480 of the bd plastipak¿ syringe package were open and had the letter p was written on it.The following information was provided by the initial reporter, translated from dutch to english: a nurse delivered us a syringe with the letter "p" written on it.This syringe came right out of the package so it was delivered that way.

• Brand Name: BD PLASTIPAK¿ SYRINGE
• 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 ; 8448235433
• MDR Report Key: 16640532
• MDR Text Key: 312508406
• Report Number: 3003152976-2023-00108
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300629
• Device Lot Number: 2212041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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