MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD DISCARDITII SYRINGE; INTRAVASCULAR CATHETER

Catalog Number 300844

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd discardit ii syringe had foreign matter the following information was received by the initial reporter with the following when removed from the packing nurse found hair inside the syringe.

Manufacturer Narrative

Customer provided photographs review: the quality engineer inspected 03 photographs of lot # 3334939 material # 300844 received for evaluation.The 1st photo showing batch details which was printing on shelf pack.Other 2 photos are showing foreign matter (hair) inside the syringe.Dhr & production record review: a review of our risk management document was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our specification requirements.However, bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.The device history record review was completed for provided lot # 3334939 material # 300844.There was no rejected inspections or quality notifications during the production of the provided lot number.Retention sample review: the retention sample were visually inspected, the defect of foreign matter was not found.Thus, the defect of foreign matter (hair) cannot be confirmed in lot # 3334939 material # 300844.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

When removed from the packing nurse found hair inside the syringe.

• Brand Name: BD DISCARDITII SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19119014
• MDR Text Key: 341033928
• Report Number: 9616066-2024-00579
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2024

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: 300844
• Device Lot Number: 3334939
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1