MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 5ML LS 24X1 DN

Catalog Number 303080

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 05/08/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Initial reporter addr 1: (b)(6).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 100 syringe 5ml ls 24x1 dn experienced damaged or open unit packaging/seal where sterility was compromised, and foreign matter in device cannula/needle/syringe or other fluid path component.The following information was provided by the initial reporter: clearly visible foreign particles, dust & insects inside the sealed pack.

Event Description

It was reported that 100 syringe 5ml ls 24x1 dn experienced damaged or open unit packaging/seal where sterility was compromised, and foreign matter in device cannula/needle/syringe or other fluid path component.The following information was provided by the initial reporter: clearly visible foreign particles, dust & insects inside the sealed pack.

Manufacturer Narrative

Investigation summary: photos were received by bd for evaluation.A quality engineer was able to review the photos of emerald 5ml from lot # 0274791 regarding item # 303083 with the reported issue of ¿clearly visible foreign particles, dust & insects inside the sealed pack¿.Dhr was reviewed for the product test.No discrepancy was reported and recorded in dhr in customer reported lot # 0274791.No samples and two photographs were received from the customer.Bd bawal has retention samples and the retention samples of 0274791 of emerald 5ml were used to simulate the reported defect and investigate the complaint.The investigating team reviewed the dhr to check for any breakdown on machine that could cause dust particle during assembling of syringe parts, no such issue found in the documented history record.The investigating team also reviewed the process of 100% inspecting verification that is performed after every preventive maintenance for segregating the defective products that can be generated post pm and no issue found.The defect is not confirmed as there is no sample and only photographs available.Since samples are not available thus the root cause could not be identified.Based on the photo(s) received the investigation concluded that bd was not able to duplicate or confirm the indicated failure.

• Brand Name: SYRINGE 5ML LS 24X1 DN
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11943690
• MDR Text Key: 254841262
• Report Number: 2243072-2021-01618
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303080
• Device Lot Number: 0274791
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1