MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLASTIPAK ¿ STERILE SYRINGE; PISTON SYRINGE

Catalog Number 302558

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: unknown.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 plastipak ¿ sterile syringe was found protruding through its packaging unit.The following information was provided by the initial reporter, translated from spanish: "at the time of receiving the material, a damaged group is detected.".

Event Description

It was reported that the bd plastipak ¿ sterile syringe was found protruding through its packaging unit.The following information was provided by the initial reporter, translated from spanish: "at the time of receiving the material, a damaged group is detected.".

Manufacturer Narrative

H6: investigation summary: two photos received by our quality team for investigation.Upon visual evaluation, damaged package is observed.A collective box broken at the top is displayed, in which it is possible to view part of the product information, therefore, it is displayed that the material was handled after delivery from the processing area.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time, it is possible incident occurred during transport.

• Brand Name: BD PLASTIPAK ¿ STERILE SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15799135
• MDR Text Key: 307810119
• Report Number: 9614033-2022-00100
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 07501073025585
• UDI-Public: (01)07501073025585
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

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: 302558
• Device Lot Number: 2193731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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