MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH SHERLOCK; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Infiltration into Tissue (1931); Pain (1994); Swelling/ Edema (4577)

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refy3823 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported " patient had chemotherapy infusion and experienced pain and swelling above the insertion site on their right arm.Upon removal of picc, a hole was seen at the 10cm mark.".

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 manufacturer has received the sample and will evaluate.Results are expected soon.

Event Description

It was reported " patient had chemotherapy infusion and experienced pain and swelling above the insertion site on their right arm.Upon removal of picc, a hole was seen at the 10cm mark." additional information received on 08/25/2022: the patient had just started the infusion of lurbinectedin and the patient noted her arm was wet.Staff stopped the infusion and flushed the picc catheter with saline and noted some swelling in the arm and the dressing was saturated.The picc was removed and i noted the hole in the picc catheter.Patient had no pain in her arm and no treatment required.We reinserted another picc the next day.

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, 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 a damaged catheter was confirmed.The product returned for evaluation was one 4fr s/l 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 at the 10cm depth marking.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.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported " patient had chemotherapy infusion and experienced pain and swelling above the insertion site on their right arm.Upon removal of picc, a hole was seen at the 10cm mark." additional information received 08/25/2022: the patient had just started the infusion of lurbinectedin and the patient noted her arm was wet.Staff stopped the infusion and flushed the picc catheter with saline and noted some swelling in the arm and the dressing was saturated.The picc was removed and i noted the hole in the picc catheter.Patient had no pain in her arm and no treatment required.We reinserted another picc the next day.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15299375
• MDR Text Key: 305416100
• Report Number: 3006260740-2022-03322
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 2194108
• Device Lot Number: REFY3823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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