MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ I.V. CATHETER; INTRAVASCULAR CATHETER

Catalog Number 388411

Device Problem Material Perforation (2205)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 insyte¿ i.V.Catheter the catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a damaged catheter.The catheter tip was damaged when punctured.

Event Description

It was reported while using bd insyte¿ i.V.Catheter the catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a damaged catheter.The catheter tip was damaged when punctured.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes d10: returned to manufacturer on: 05jul2023 h6: investigation summary our quality engineer inspected the 5 photos and 1 used sample submitted for evaluation.The reported issue of catheter defective / damaged was confirmed upon inspection of the photos and sample.Analysis of the photos and sample showed that there was catheter damage near the catheter tip.An examination of the physical sample confirmed the presence of a ¿v-cut¿ at the catheter tip.Based off the damage observed, there is a slight chance that during use the needle could have pierced through the catheter, resulting in the ¿v-cut¿ due to the shape of the needle bevel.Bd could not determine an exact root cause since we are unable to confirm how the product was exactly used.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: BD INSYTE¿ I.V. 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17358109
• MDR Text Key: 320170052
• Report Number: 8041187-2023-00353
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/01/2023

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: 388411
• Device Lot Number: 2176905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2022
• 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