MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383083

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Extravasation (1842)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one bd intima-ii¿ closed iv catheter system has been found containing mixed product during use.The following has been provided by the initial reporter: it was found extravasation, catheter was shorter than usual, and felt dull.(b)(6): after the puncture ended the afternoon of the stay, an external seepage occurred, and after the nurse pulled out the needle, checked the length of the catheter and found that the catheter was shorter than usual.Other nurses also reacted to this batch of retention needles obviously feel the strong feeling of the back-retracting needle core, not good to fight, affecting the success rate of puncture.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 8262052.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 because the needle was removed from the returned sample our engineers were unable to evaluate the retraction speed.Comparison to the retention samples for this lot determined that the shortened catheter was most likely the result of mixed products.The shorter catheter is by design for our 0.56in variant of the product.Personnel failing to follow line clearance protocols serves as the most likely origin for this non-conformance.H3 other text : see h.10.

Event Description

It has been reported that one bd intima-ii¿ closed iv catheter system has been found containing mixed product during use.The following has been provided by the initial reporter: it was found extravasation, catheter was shorter than usual, and felt dull.Google translation: after the puncture ended the afternoon of the stay, an external seepage occurred, and after the nurse pulled out the needle, checked the length of the catheter and found that the catheter was shorter than usual.Other nurses also reacted to this batch of retention needles obviously feel the strong feeling of the back-retracting needle core, not good to fight, affecting the success rate of puncture.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 8837388
• MDR Text Key: 152531619
• Report Number: 3006948883-2019-00602
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

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: Health Professional
• Device Expiration Date: 10/12/2021
• Device Catalogue Number: 383083
• Device Lot Number: 8262052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 05/16/2019
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other