MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD BD DISCARDITII 5ML SYRG; INTRAVASCULAR CATHETER

Catalog Number 300850

Device Problem Break (1069)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that bd discarditii 5ml syrg was damaged the following information was received by the initial reporter with the following verbatim: lotus labs is cro , while drawing samples for the discardit 5ml syringes have broken.

Manufacturer Narrative

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

Manufacturer Narrative

A quality engineer inspected the 06 samples (02 contaminated + 04 packed) and 03 photographs of lot # 3308175 material # 300850 submitted for evaluation.The reported issue of ¿crack barrel¿ was confirmed upon inspection of the physical samples.Analysis of the samples showed that there was issue of crack barrel was available.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.Based on the return samples, the 2 samples were contaminated and 4 were seal packed.The barrel was crack in contaminated samples.3 photos of discardit syringe 5 ml lot no.# 3308175 material # 300850 received and evaluated.The 1st image showing the lot number details in box 2nd image showing the syringe holding in hand inside some poly bag.3rd image showing contaminated open syringe.From image its not confirming that barrel is crack or not.The investigation and simulation carried out on the retained samples at our end for the lot no # 3308175 material # 300850.But there were not any barrel crack defect observed in retained samples.The device history record review was completed for provided lot no.# 3308175 material # 300850 there was no rejected inspections or quality notifications during the production of the provided lot number.Its not confirmed that from where barrel has been cracked either from manufacturing or in transition.

Event Description

Lotus labs is cro , while drawing samples for the discardit 5ml syringes have broken.

• Brand Name: BD BD DISCARDITII 5ML SYRG
• 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: 18862731
• MDR Text Key: 337306716
• Report Number: 2243072-2024-00261
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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: 300850
• Device Lot Number: 3308175
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1