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

Catalog Number 383426

Device Problem Contamination (1120)

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

Event Date 07/28/2018

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 plus¿ had foreign matter in the tubing.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 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 manufacture: no.The batch record for lot#7265023 was reviewed, no related abnormalities were found during the manufacturing process.The actual sample was provided by the customer for this complaint.The actual sample was evaluated and did show the reported failure mode in which confirmed this complaint.The extension tubing of the returned sample, bd engineers noted a red foreign matter in the extension tubing of the device.As per request, ftir analysis was completed on the reddish material observed in the tubing of the sample.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely blood along with human skin flake.Root cause cannot be confirmed.

Event Description

It was reported that a bd intima ii plus had foreign matter in the tubing.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD INTIMA II PLUS¿
• Type of Device: CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 7807549
• MDR Text Key: 118104995
• Report Number: 3006948883-2018-00150
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/09/2020
• Device Catalogue Number: 383426
• Device Lot Number: 7265023
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 08/03/2018
• Supplement Dates FDA Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other