MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, 18 GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redp3030 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redp3030) have been reported from the same facility.
Event or Problem Description
It was reported that the tm was at a facility and they had two catheters that when they activated the needle, it did not retract.This caused them to pull the whole thing out and lose access.This report addresses the second device.
Event or Problem Description
It was reported that the tm was at a facility and they had two catheters that when they activated the needle, it did not retract.This caused them to pull the whole thing out and lose access.This report addresses the second device.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of the needle failing to withdraw upon safety activation was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one accucath peripheral iv catheter assembly.The sample was received with the safety mechanism depressed and the needle fully withdrawn into the housing.The catheter was not returned for evaluation.The safety mechanism was deactivated and reactivated several times.Activation of the safety was successful and unremarkable each time.Microscopic inspection of the sample did not reveal any damage, deformation or evidence of safety activation failure.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.A lot history review (lhr) of redp3030 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redp3030) have been reported from the same facility.

• Brand Name: ACCUCATH, 18 GX2.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9082958
• Report Number: 3006260740-2019-02727
• Device Sequence Number: 2665270
• Product Code: FOZ
• UDI-Device Identifier: 00801741110931
• UDI-Public: (01)00801741110931
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AC0182250
• Device Lot Number: REDP3030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1