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

Catalog Number 391591

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  

Event Description

It was reported that bd venflon catheter had foreign matter.The following information was received by the initial reporter with the following verbatim: our sub stockiest purchased stock from our super stockiest nikesh ent, stock kept in their warehouse, at the time of stock verification identified that 3 items infested by pest inside the boxes only, outside carton is looking good and safe.

Manufacturer Narrative

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

Manufacturer Narrative

15 samples and 03 photos were received by bd for evaluation of the returned samples for the reported issue of foreign matter from lot # 3342743 product # 391591.First photograph shows empty shelf packs in a pile on the floor.Second photograph shows a pile of unit pack in a pile inside a case carton.Third photograph shows a pile of unit packs with a brown color substance on one unit pack.The photograph does not confirm whether the brown substance is pest infestation, but it shows sign of foreign matter.The original customer returned sample was used to investigate the complaint of foreign matter and it was found that the sample shows said defect of foreign matter in it.Inspection of (b)(6) retention samples was conducted where the investigating team has visually inspected the samples for foreign matter and no foreign matter was found in the (b)(6) retention samples.Since the retention samples showed no sign of any contamination, the exact root cause could not be determined.The probable root cause is that the product was infested by foreign matter (pests) at the warehouse/storage/distribution center locations.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

Event Description

Our sub stockiest purchased stock from our super stockiest nikesh ent, stock kept in their warehouse, at the time of stock verification identified that 3 items infested by pest inside the boxes only, outside carton is looking good and safe.

• Brand Name: BD VENFLON CATHETER
• 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: 19113481
• MDR Text Key: 341007662
• Report Number: 2243072-2024-00550
• 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
• Report Date: 03/29/2024

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: 391591
• Device Lot Number: 3342743
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1