MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Extravasation (1842)

Event Date 07/07/2022

Event Type  Injury  

Event Description

It was reported patient receiving chemotherapy via picc line.Contacted nursing staff to alert that area around the insertion site was wet.Chemotherapy stopped.Line flushed.Nic informed.Discussed with and assessed by medical team.Linogram arranged and attended for same area treated as per local extravasation policy.Picc line removed.Arranged for reinsertion with infusional services following day.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refy1412 showed one other similar product complaint(s) from this lot number.

Manufacturer Narrative

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), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak was confirmed.The product returned for evaluation was one 4 fr single lumen 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 approximately 6.5 cm dist.To molded joint.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.

Event Description

It was reported patient receiving chemotherapy via picc line.Contacted nursing staff to alert that area around the insertion site was wet.Chemotherapy stopped.Line flushed.Nic informed.Discussed with and assessed by medical team.Linogram arranged and attended for same area treated as per local extravasation policy.Picc line removed.Arranged for reinsertion with infusional services following day.Additional information received: "there is no evidence of tissue damage.Treatment was an irritant.The immediate treatment patient received was infusion stopped, iv device aspirated, medical team contacted/pharmacy contacted, cold pack for 20 minutes every 4 hours for 24 hours, arm elevated, topical hydrocortisone 1% cream every 6 hours for up to 7 days.Follow up the following 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.

Event Description

It was reported patient receiving chemotherapy via picc line.Contacted nursing staff to alert that area around the insertion site was wet.Chemotherapy stopped.Line flushed.Nic informed.Discussed with and assessed by medical team.Linogram arranged and attended for same area treated as per local extravasation policy.Picc line removed.Arranged for reinsertion with infusional services following day.Additional information received: treatment was an irritant.The immediate treatment she received was infusion stopped, iv device aspirated, medical team contacted/pharmacy contacted, cold pack for 20 minutes every 4 hours for 24 hours, arm elevated, topical hydrocortisone 1% cream every 6 hours for up to 7 days".

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM
• 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: 15164408
• MDR Text Key: 297240040
• Report Number: 3006260740-2022-03040
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• 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: REFY1412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• 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): Required Intervention