MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 14 G X 1.88 IN. BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER MADE OF FEP POLYMER

Catalog Number 381167

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Pain (1994)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device evaluation: result - a sample was not returned for evaluation.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 4300709.A quality notification review revealed no findings associated to the reported failure mode or other events that could be related to the complaint.During this lot, qa performed a tubing 14g/hub pull test to 40 samples and found no values out of specification.Conclusions - bd was not able to duplicate or confirm the customer's indicated failure mode.As there was no actual returned sample for evaluation, an absolute root cause for this incident cannot be determined.

Event Description

It was reported that six days after placement of the suspect device, the patient felt pain.It was noted when the device was removed, the catheter had broken off in the vein.The broken catheter was removed surgically with a 2 cm incision requiring 3 stitches.

• Brand Name: 14 G X 1.88 IN. BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER MADE OF FEP POLYMER
• Type of Device: PERIPHERAL VENOUS CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5354163
• MDR Text Key: 35440869
• Report Number: 9610847-2016-00001
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K950301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 381167
• Device Lot Number: 4300709
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention