MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PPICC SOLO 4FR S/L, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Erythema (1840); Pain (1994); Swelling/ Edema (4577)

Event Date 11/25/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A batch history review (bhr) of refw2335 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the customer that the device was inserted (b)(6) 2022 by one of our specialist inserters under ecg guidance.Line was located in l) basilic vein.Staff advise patient presented for routine review however on assessment it was noted there was pain and leaking at picc insertion site when line was being flushed.Dressing was removed.Picc line removed, noted fracture in picc line approx.5-10cm down picc.Nil surrounding erythema or swelling of arm.Mark at skin was 6cm, skin to hub measurement 16cm.No other information was provided.

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, applicable previous investigation(s), complaint and lot history, applicable manufacturing records, sample, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak in the catheter was confirmed.The product returned for evaluation was a 4fr sl powerpicc solo catheter.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated and a split was observed between the 10 and 11cm mark.The catheter split contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: damage which was circumferentially aligned.Fracture edges which were rounded and polished due to repeated material wear.'c' shaped impressions leading into the fracture site which are consistent with material buckling due to movement which caused the fracture edges to be pressed together.Overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing).An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.The damage location suggested that catheter securement, access and maintenance techniques may have contributed.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported by the customer that the device was inserted (b)(6) 2022 by one of our specialist inserters under ecg guidance.Line was located in l) basilic vein.Staff advise patient presented for routine review however on assessment it was noted there was pain and leaking at picc insertion site when line was being flushed.Dressing was removed.Picc line removed, noted fracture in picc line approx.5-10cm down picc.Nil surrounding erythema or swelling of arm.Mark at skin was 6cm, skin to hub measurement 16cm.No other information was provided.

• Brand Name: PPICC SOLO 4FR S/L, 3CG
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16359685
• MDR Text Key: 309389708
• Report Number: 3006260740-2023-00415
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 22194118
• Device Lot Number: REFW2335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/11/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other