MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNSPECIFIED BD¿ CATHETER

Catalog Number UNKNOWN

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd¿ catheter needle was difficult to retract and the needle was bent.The catheter had pressured out on 3 occasions during use.The following information was provided by the initial reporter: material no.: unknown batch no.: unknown.It was reported that the needle felt sticky and difficult to retract the needle and the needle was bent after it was pulled out.It was also reported that the catheter pressured out.Just wanted to let you know that one of the nurse showed me a 22 gauge diffusics angio that felt sticky.They pulled the needle back a little prior to sticking a patient, this is the normal process they do to make sure that the needle is ok.This is when the nurse felt that it was difficult (sticky) and did not use that diffusics catheter.They also stated that it was harder to disengage the gray end once they pulled the needle all the way back and the needle was curved.Later in the day i asked if there were any more issues with the #22 angio.She stated that there was not another ¿sticky¿ one but that 3 times the ct tech stated that the #22 diffusic pressured out.There was no infiltrates but it was brought to the nurses attention.I talked with the nurse that was there the day before and she had no issues with the diffusics.

Event Description

It was reported that unspecified bd¿ catheter needle was difficult to retract and the needle was bent.The catheter had pressured out on 3 occasions during use.The following information was provided by the initial reporter: material no.: unknown batch no.: unknown.It was reported that the needle felt sticky and difficult to retract the needle and the needle was bent after it was pulled out.It was also reported that the catheter pressured out.Just wanted to let you know that one of the nurse showed me a 22 gauge diffusics angio that felt sticky.They pulled the needle back a little prior to sticking a patient, this is the normal process they do to make sure that the needle is ok.This is when the nurse felt that it was difficult (sticky) and did not use that diffusics catheter.They also stated that it was harder to disengage the gray end once they pulled the needle all the way back and the needle was curved.Later in the day i asked if there were any more issues with the #22 angio.She stated that there was not another ¿sticky¿ one but that 3 times the ct tech stated that the #22 diffusic pressured out.There was no infiltrates but it was brought to the nurses attention.I talked with the nurse that was there the day before and she had no issues with the diffusics.

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.Although photos were submitted for evaluation, they did not display the failure mode clearly enough to identify the root cause.Unfortunately, the root cause for this complaint could not be determined at the conclusion of our review.

• Brand Name: UNSPECIFIED BD¿ CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8712314
• MDR Text Key: 151018271
• Report Number: 9610847-2019-00423
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other