MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F NURSE BASIC TRAY (DUAL-LUMEN) (WITH MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3295118
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of rean1310 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when infusion therapy was given on the same day, the nurse found that the there was severe fracture at the intersection of the bifurcation and the extension tube, and the catheter was removed.The catheter was broken during the removal of the catheter.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a fracture in the extension tubing was confirmed and the cause appears to be use related.The product returned for evaluation was a 5fr d/l powerpicc catheter.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as scissors or scalpel.The returned product sample was evaluated and a break was observed at the proximal interface of the molded joint and extension tubing, on the red-luered lumen.Microscopic examination of the 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.Care should be taken when using sharp-edged instruments near the product, and the product instruction for use (ifu) was found to contain the following information which may be relevant to this type of event, "avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps." an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is invalid.
Event or Problem Description
It was reported that when infusion therapy was given on the same day, the nurse found that the there was severe fracture at the intersection of the bifurcation and the extension tube, and the catheter was removed.The catheter was broken during the removal of the catheter.

• Brand Name: POWERPICC SOLO CATHETER 5F NURSE BASIC TRAY (DUAL-LUMEN) (WITH MICROINTRODUCER)
• 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: 7574089
• Report Number: 3006260740-2018-01240
• Device Sequence Number: 16772924
• Product Code: LJS
• UDI-Device Identifier: 00801741028090
• UDI-Public: (01)00801741028090
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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: 3295118
• Device Catalogue Number: 3295118
• Device Lot Number: REAN_1310 (INVALID)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1