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

Catalog Number 300849

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.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 discarditii syringe was labeled incorrectly the following information was received by the initial reporter with the following verbatim: we have come across another date of manufacturing mis-match issue between label and coc.The label and coc is attached herewith this mail, while the pir numbers are quoted below.Please ensure to issue the corrected coc as soon as possible as the product is now stuck at the customer location in grn.If not sorted soon may raise rejection.

Manufacturer Narrative

No samples and 01 photographs were received by bd for evaluation.We have checked the coc & found that wrong manufacturing date was mentioned in the coc.We immediately correct the coc as per product record.

Event Description

We have come across another date of manufacturing mis-match issue between label and coc.The label and coc is attached herewith this mail, while the pir numbers are quoted below.Please ensure to issue the corrected coc as soon as possible as the product is now stuck at the customer location in grn.If not sorted soon may raise rejection.

• 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: 18968850
• MDR Text Key: 338755248
• Report Number: 2243072-2024-00437
• 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: 04/03/2024

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: 300849
• Device Lot Number: 3361293
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1