MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 2ML LS; PISTON SYRINGE

Catalog Number 302204

Device Problem Packaging Problem (3007)

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

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

Two photos were received by our quality team for evaluation.From the photos, the individual blister packages top web was observed to be torn.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The primary and secondary packaging processes were reviewed.The team was unable to identify any contact point that could result in the package torn on the top web during operation.However, as no samples were received for further analysis, the root cause could not be determined.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

Event Description

It was reported when using the syringe bd 2ml ls, the device experienced damaged or open unit package/ seal where sterility of the product is compromised.This event occurred 27 times.The following information was provided by the initial reporter.The customer stated: syringe packaging has been torn.

• Brand Name: BD SYRINGE 2ML LS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12484552
• MDR Text Key: 271916237
• Report Number: 8041187-2021-00846
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302204
• Device Lot Number: 0107636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• 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