MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER LOK SYRINGE; PISTON SYRINGE

Catalog Number 303310

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9051839, medical device expiration date: 2024-02-29, device manufacture date: 2019-04-29.Medical device lot #: 8344731, medical device expiration date: 2023-12-31, device manufacture date: 2019-02-18.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 luer lok¿ syringe packaging was difficult to open properly during use, resulting in torn shards of packaging paper entering the sterile operating room.Lot # 9051839 had 16 occurrences of this event, while lot # 8344731 had 1 occurrence; however, the dates of these occurrences are unknown.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "package is difficult to open properly.This is an ongoing issue.Package is difficult to open and tearing results in potential compromise of sterile field in operating room.".

Manufacturer Narrative

Investigation: fifteen samples received for investigation, the samples are opened and could not be evaluated for the reported defect, however ten retention samples were evaluated for package tearing and fiber tear in the package.No defects observed.Dhr was completed with no irregularities.The parameters for the failure mode reported by the customer (pressure, temperature and sealing time) were within the validated operation window.

Event Description

It was reported that the bd luer lok¿ syringe packaging was difficult to open properly during use, resulting in torn shards of packaging paper entering the sterile operating room.Lot # 9051839 had 16 occurrences of this event, while lot # 8344731 had 1 occurrence; however, the dates of these occurrences are unknown.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "package is difficult to open properly.This is an ongoing issue.Package is difficult to open and tearing results in potential compromise of sterile field in operating room.".

• Brand Name: BD LUER LOK 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9521545
• MDR Text Key: 198361249
• Report Number: 9614033-2019-00300
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303310
• Device Lot Number: SEE SECTION H.10.
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other