MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 16G X 1.16IN (1.7 X 30 MM) ANGIOCATH; INTERVASCULAR CATHETER

Catalog Number 381154

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/05/2019

Event Type  Injury  

Manufacturer Narrative

The lot# is unknown but the customer provided 3 possible lot#s.The information for each lot number is as follows: medical device lot #: 6063764; expiration date: 2021-03-31; manufacture date: 2016-04-04.Medical device lot #: 4325585; expiration date: 2019-12-31; manufacture date: 2015-01-05.The reported lot# 7051292 was not found for the catalog number.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 catheter broke during use with a 16g x 1.16in (1.7 x 30 mm) angiocath.The following information was provided by the initial reporter, "during the removal of the catheter they realized that a part of it remained in the vein.An urgent ultrasound scan was performed and the broken catheter was removed by a surgical intervention.The list of medicines that was used with the catheter: cefamezin iv 1fl 1g+f 10 ml; tranex os iv 6f 5 ml 500 mg; cefazolina teva iv f 1g+f 10 ml; elettrolitica reintegro na 20 sacc 500 ml; sodio cloruro 0.9 %; flexen iv 6f 100 mg+6 f 5 ml; plasil iniettabile 5f 10mg/2ml; morfina cl 5f 1ml 10mg/ml; perfalgan ev 10mg/ml 100 ml.".

Event Description

It was reported that a catheter broke during use with a 16g x 1.16in (1.7 x 30 mm) angiocath.The following information was provided by the initial reporter, "during the removal of the catheter they realized that a part of it remained in the vein.An urgent ultrasound scan was performed and the broken catheter was removed by a surgical intervention.The list of medicines that was used with the catheter: cefamezin iv 1fl 1g+f 10 ml, tranex os iv 6f 5 ml 500 mg, cefazolina teva iv f 1g+f 10 ml, elettrolitica reintegro na 20 sacc 500 ml, sodio cloruro 0.9 %, flexen iv 6f 100 mg+6 f 5 ml, plasil iniettabile 5f 10mg/2ml, morfina cl 5f 1ml 10mg/ml, perfalgan ev 10mg/ml 100 ml.".

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 6063764, 7051295, and 4325585.Our records show that this is the only instance of this issue occurring in any of these production batches.According to the sampling plan applied for product performance, these lots were accepted and released without defects being noted during the final assembly or visual inspections.Additionally pull force testing was conducted on the representative samples submitted.Testing results for the representative samples met product specifications, unfortunately, the root cause for this complaint could not be determined at the conclusion of our review.

• Brand Name: 16G X 1.16IN (1.7 X 30 MM) ANGIOCATH
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9256508
• MDR Text Key: 180441454
• Report Number: 9610847-2019-00653
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• 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: 12/27/2019

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 Catalogue Number: 381154
• Device Lot Number: SEE H.10
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention