MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ANGIOCATH PLUS¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 382444

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

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 prior to using the bd angiocath plus¿ iv catheter there was silicone overflow in catheter tube.The following information was provided by the initial reporter: silicone overflow in catheter tube.

Manufacturer Narrative

H6: investigation summary one sample in open packaging was received by our quality team for evaluation.The sample was subjected to visual inspection.Under 20x magnification, small lumps of transparent, gel-like substance were observed on the surface of the catheter tubing.However, the lubricant appearance was found to be acceptable.Tip spear damage was also observed on the catheter tip.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the returned samples, small lumps of transparent, gel-like substances observed on the catheter tubing were most likely to be excessive lubricant that aggregated and formed small lumps on the catheter surface.Given the gel-like nature of the lube, it was possible for the lubricant to flow to different locations on the catheter during transportation or storage.The lubricant appearance on the returned samples was found to be acceptable.For the unreported tip spear damage that was observed on the catheter tip, there is an 100% inline vision inspection system at the main assembly line to detect and fail samples with tip spear.This is most likely caused by the user handling during needle cover removal or during insertion.The actual root cause could not be established as the sample was returned in open packaging.

Event Description

It was reported prior to using the bd angiocath plus¿ iv catheter there was silicone overflow in catheter tube.The following information was provided by the initial reporter: silicone overflow in catheter tube.

• Brand Name: BD ANGIOCATH PLUS¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15245364
• MDR Text Key: 305370991
• Report Number: 8041187-2022-00474
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382444
• Device Lot Number: 1298051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1