MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ANGIOCATH PLUS¿ I.V. CATHETER 20GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number 382434

Device Problem Defective Device (2588)

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

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd angiocath plus¿ i.V.Catheter 20ga x 1.16in the catheter was torn.There was no report of patient impact.The following information was provided by the initial reporter.Catheter tube is torn.

Manufacturer Narrative

The following fields were updated due to additional information: the information for additional lot number is as follows: d4.Medical device lot #: 2087454.D4.Medical device expiration date: 31-mar-2027.H4.Device manufacture date: 28-mar-2022.D10: device available for eval?: yes.D.10: returned to manufacturer on: 10-aug-2022.H.6.Investigation summary: one photo and seven samples were received by our quality team for evaluation.The photo was subjected to visual inspection to check for catheter damage.From the photo, a white / transparent substance protruding out from the catheter tip was observed.Six samples from batch 2087454 and 1 sample from batch 2087454 was received.The samples were subjected to visual inspection to check for catheter damage.No catheter damage or foreign substance was observed on all seven samples.For samples 1 and 6, under 20x magnification, a small lump of a transparent, gel-like substance was observed on the surface of the catheter tubing.However, the lubricant appearance was found to be acceptable.For samples 2, 3, 4, and 7, under 20x magnification, small droplets of transparent, gel-like substances were observed on the surface of the catheter tubing, however, the lubricant appearance was found to be acceptable.For sample 5, under 20x magnification, no visible lump or droplet of transparent, gel-like substance was observed on the surface of the catheter tubing.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.H3 other text : see h10.

Event Description

It was reported while using bd angiocath plus¿ i.V.Catheter 20ga x 1.16in the catheter was torn.There was no report of patient impact.The following information was provided by the initial reporter: catheter tube is torn.

• Brand Name: BD ANGIOCATH PLUS¿ I.V. CATHETER 20GA X 1.16IN
• 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: 15211060
• MDR Text Key: 302508612
• Report Number: 8041187-2022-00454
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

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: 382434
• Device Lot Number: 2087453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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