MAUDE Adverse Event Report: BD (SUZHOU) UNSPECIFIED BD¿ CATHETER; CATHERTER

Catalog Number 383941

Device Problems Burst Container or Vessel (1074); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary a device history review was conducted for lot number 8302712.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately a sample could not be obtained for evaluation and testing.However, based on previous evaluations and the description of the event, they were able to determine that the most likely root cause for this event is the forcing of fluid through the device during injection.The bd pegasus is an infusion only device and is not rated for high pressure injections.Bd will continue to track and trend for this issue.

Event Description

It was reported that during use of the unspecified bd¿ catheter in the process of ct-enhanced contrast injection during the injection of a closed needle-proof intravenous indwelling needle for the patient, a large amount of contrast agent infiltrated into the frame.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: the catheter was used for ct examination, the tubing was exploded during the developer injection.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8302712.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately a sample could not be obtained for evaluation and testing.However, based on previous evaluations and your description of the event, they were able to determine that the most likely root cause for this event is the forcing of fluid through the device during injection.

Event Description

It was reported that during use of the unspecified bd¿ catheter in the process of ct-enhanced contrast injection during the injection of a closed needle-proof intravenous indwelling needle for the patient, a large amount of contrast agent infiltrated into the frame.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: the catheter was used for ct examination, the tubing was exploded during the developer injection.

• Brand Name: UNSPECIFIED BD¿ CATHETER
• Type of Device: CATHERTER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 8550448
• MDR Text Key: 145113834
• Report Number: 3006948883-2019-00299
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 383941
• Device Lot Number: 8302712
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other