MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER 4F FULL TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
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 redp1831 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that nurse let patient alone for 5 minutes and when she returned to the room there was blood everywhere.She stated it looked like the patient pulled on his catheter so hard that it snapped a clean cut.It was reported that there is a visible white line like the catheter was distressed.The catheter was fully intact with the securcath.
Event or Problem Description
It was reported that nurse let patient alone for 5 minutes and when she returned to the room there was blood everywhere.She stated it looked like the patient pulled on his catheter so hard that it snapped a clean cut.It was reported that there is a visible white line like the catheter was distressed.The catheter was fully intact with the securcath.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken catheter is confirmed and was determined to be use related.One 4 fr single lumen powerpicc was returned for evaluation.An initial visual observation showed a break in the catheter near the 2 cm depth marker, approximately 3.5 cm distal to the molded joint.Use residue was observed throughout the sample.Whitening of the catheter material was observed at the break sites and approximately 2.2 cm proximal to the break.A microscopic observation revealed the break sites were very flat and smooth with a granular surface texture.Superficial cracks were observed in the catheter approximately 2.2 cm proximal to the break site, and slight tensile weakness was observed at this location.The observed characteristics of the break in the returned catheter suggest the catheter failed due to excessive tensile (pulling) force, which also aligns with the reported description of the event.

• Brand Name: POWERPICC CATHETER 4F FULL TRAY (SINGLE-LUMEN)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8960030
• Report Number: 3006260740-2019-02588
• Device Sequence Number: 2585467
• Product Code: LJS
• UDI-Device Identifier: 00801741027574
• UDI-Public: (01)00801741027574
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2019

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: 3174108
• Device Lot Number: REDP1831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 09/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1