MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BASIC KIT 18G X 10 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
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 catheter tubing separating from the luer connector was confirmed; however, the root cause of the event was not identified.The product returned for evaluation was one photograph depicting an 18ga x 10cm powerglide pro midline catheter.Usage residues were observed on the depicted sample.An extension set was attached to the luer adapter.The catheter was completely separated from the luer adapter.It could not be determined from the photograph if the catheter tubing was detached or broken.While device damage was evident in the submitted photograph, inspection of that photograph was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.The length of time between device placement and catheter separation suggested that use conditions may have contributed to the event.Potential contributing factors include sharp instrument contact, material fatigue and tensile (pulling) stress.A lot history review (lhr) of recx2679 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the powerglide was placed on 4/25.Line was 18 days old.In the am, nurse went to flush the line and noted it squirted all over.It was stated the nurse looked closer and the hub (green) had disconnected from the tubing.The tubing was sticking out of the pt about 1cm.Nurse was able to grab the catheter and remove it completely.

• Brand Name: BASIC KIT 18G X 10 CM WITH BIOPATCH
• 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: 8675754
• Report Number: 3006260740-2019-01565
• Device Sequence Number: 11351428
• Product Code: FOZ
• UDI-Device Identifier: 00801741140518
• UDI-Public: (01)00801741140518
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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 Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: F318107T
• Device Lot Number: RECX2679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1