MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CATHETER; INTERVASCULAR CATHETER

Catalog Number 383078

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2018

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 that a bd intima-ii¿ catheter had leakage due to slim pinch clamp that is crooked and loose.This clamp does not effectively seal the tube.There was no report of exposure, serious injury or medical intervention.

Event Description

It was reported that a bd intima-ii catheter had leakage due to slim pinch clamp that is crooked and loose.This clamp does not effectively seal the tube.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

The batch record for lot#8017209 was reviewed, no related abnormalities were found during the manufacturing process.A sample and photo were received for the purpose of our investigation.The investigators were able to observe the reported failure mode in the sample provided, with both the sample and photos provided show that the pinch clamp of the unit was only partially activated.Inspection of the pinch clamp's parameters found the component to be conforming to product specifications.Bd will continue to track and trend for this issue.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.

Event Description

It was reported that a bd intima-ii¿ catheter had leakage due to slim pinch clamp that is crooked and loose.This clamp does not effectively seal the tube.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD INTIMA-II¿ CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 7782750
• MDR Text Key: 117268134
• Report Number: 3006948883-2018-00149
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830787
• UDI-Public: 382903830787
• 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,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 383078
• Device Lot Number: 8017209
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other