MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. UNSPECIFIED BD CATHETER; INTERVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 07/23/2019

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 the intima-ii 22 ga x 0.75 in prn slm experienced leakage during use.The following information was provided by the initial reporter: it's noticed that blood leakage at the connection site between ext.Tubing and catheter junction.

Manufacturer Narrative

Investigation: unfortunately a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.Additionally leakage testing of the returned device was able to identify a small breach in the catheter tubing that resulted in the observed leak.A review of our manufacturing determined that the damage to the catheter tubing could not have been sustained during the manufacturing process, because of the dimensions of the wound.Unfortunately, the root cause for this complaint could not be determined at the conclusion of our review.

Event Description

It was reported that the unspecified bd catheter experienced leakage during use.The following information was provided by the initial reporter: it's noticed that blood leakage at the connection site between ext.Tubing and catheter junction.

Manufacturer Narrative

The following information has been updated: b.5.Describe event or problem: it was reported that the unspecified bd catheter experienced leakage during use.The following information was provided by the initial reporter: it's noticed that blood leakage at the connection site between ext.Tubing and catheter junction.D.1.Medical device brand name: unspecified bd catheter.D.4.Medical device catalog #: unknown.D.4.Medical device lot #: unknown.D.4 device expiration date: unknown.D.4.Unique identifier (udi) #: unknown.G.5.Pma/510(k)#: unknown.H.4.Device manufacture date: unknown h3 other text: see h.10.

Event Description

It was reported that the unspecified bd catheter experienced leakage during use.The following information was provided by the initial reporter: it's noticed that blood leakage at the connection site between ext.Tubing and catheter junction.

• Brand Name: UNSPECIFIED BD CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 8899314
• MDR Text Key: 155975438
• Report Number: 3006948883-2019-00658
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2019

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: Other
• Device Expiration Date: 06/12/2021
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2019
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 07/31/2019; 07/31/2019
• Supplement Dates FDA Received: 08/21/2019; 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other