MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383078

Device Problems Break (1069); Fracture (1260)

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

Event Date 08/29/2021

Event Type  malfunction  

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system split and broke from the hub during use.The following information was provided by the initial reporter, translated from (b)(6) to english: " the catheter tube was fractured, but it was not found in the body of the film.It was preliminary determined that the child had bitten off and swallowed.The substance similar to catheter was found later, and it was sent back to the factory to determine whether it was a catheter.".

Manufacturer Narrative

Investigation summary: in response to the event reported, a device history review was conducted for lot number 9050858.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.According to feedback, the broken catheter is most likely related to the behavior of the patient and unrelated to the manufacturing process.To rule out the possibility of a systemic issue in the reported lot, the retention samples have been tested for tensile resistance and were found to conform to product specifications.Unfortunately without the ability to inspect the affected device, the root cause cannot be confirmed at this time.Bd will continue to track and trend for this issue.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system split and broke from the hub during use.The following information was provided by the initial reporter, translated from chinese to english: " 1.The catheter tube was fractured, but it was not found in the body of the film.It was preliminary determined that the child had bitten off and swallowed.2.The substance similar to catheter was found later, and it was sent back to the factory to determine whether it was a catheter.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-10-09 h6: investigation summary a device history review was conducted for lot number 1050044.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.According to feedback from the facility, the broken catheter is most likely related to the behavior of the patient and unrelated to the manufacturing process.Additionally the affected sample was returned to our facility.Our engineers inspected the device under microscope, and identified whitening of the catheter tubing near the broken edge.This observation is indicative of the application of tensile force to the tubing.Also a material suspected of being the remnant tubing was returned.This material was subjected to compositional testing, and found to be a polyamide resin, which is inconsistent with the composition of the catheter tubing.Based on these observation our engineers were unable to associate this non-conformance with the manufacturing process.See h10.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12523336
• MDR Text Key: 280834245
• Report Number: 3014704491-2021-00159
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/26/2024
• Device Catalogue Number: 383078
• Device Lot Number: 1050044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2021
• 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