MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F NURSE FULL TRAY WITH MICROI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 redq3996 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the purple lumen on powerpicc was noted to be cracked when flushing, saline coming out of opening.Picc line was pulled.
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 damaged catheter was confirmed, and the cause appears to be use related.The product returned for evaluation was one fr dual lumen powepicc.The investigation findings are consistent with catheter damage caused by contact with a sharp-edged instrument such as scissors or a scalpel.The returned product sample was evaluated and a ¿v¿-shaped split was observed the extension leg of the purple lumen approximately 0.5 cm proximal to the bifurcation.Microscopic examination of the catheter split confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.Sharply formed fracture edges.Planar shape to the fracture surface.Blood residue was seen on the sample which showed that the product had undergone at least some use.The product ifu states: ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smoothedged atraumatic clamps or forceps¿ and ¿do not use scissors to remove dressing to minimize the risk of cutting catheter.¿ an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of redq3996 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the purple lumen on powerpicc was noted to be cracked when flushing, saline coming out of opening.Picc line was pulled.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F NURSE FULL TRAY WITH MICROI
• 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: 9548511
• Report Number: 3006260740-2019-04058
• Device Sequence Number: 11346442
• Product Code: LJS
• UDI-Device Identifier: 00801741034541
• UDI-Public: (01)00801741034541
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 1275108
• Device Lot Number: REDQ3996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1