MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 6F NURSE BASIC TRAY (TRIPLE-LUMEN)(MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2018
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the customer that ¿51 cm end intact or broken off - picc line discontinued and found lumen quality defective - flattened, thinned saline flushes through side of catheter - placed in patient for htpt (b)(6) discontinued on (b)(6) - di states line should be 43 cm (line is 43 cm).¿.
Additional 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, 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 damaged catheter is confirmed and was determined to be use related.One 4 fr single lumen powerpicc solo was returned for evaluation.An initial visual observation showed the catheter was stretched thin and flat and was plastically deformed in multiple locations distal to the 25 cm depth marker.Use residue was observed throughout the returned sample.The sample was flushed with a 12 ml syringe of water and leakage was observed near the 27 cm depth marker, which was within the largest stretched/ballooned section of the catheter.A microscopic observation revealed a large amount of blood residue at the distal tip of the catheter.A few other, smaller aneurysms were observed in the catheter during microscopic observation.The characteristics of the damage observed on the returned catheter suggest gradual internal over-pressurization likely caused the ballooning of the catheter tubing.The product ifu states: ¿do not use a syringe smaller than 10 ml to flush and confirm patency.Patency should be assessed with a 10 ml syringe or larger with sterile normal saline.Upon confirmation of patency, administration of medication should be given in a syringe appropriately sized for the dose.Do no infuse against resistance¿ and ¿prolonged infusion pressure greater than 25 psi may damage blood vessels or viscus.¿ the product ifu also contains suggested maintenance instructions to help prevent occlusions a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the customer that ¿51 cm end intact or broken off - picc line discontinued and found lumen quality defective - flattened, thinned saline flushes through side of catheter - placed in patient for htpt nov 13th discontinued on dec 27th - note: di states line should be 43 cm (line is 43 cm).¿.

• Brand Name: POWERPICC SOLO CATHETER 6F NURSE BASIC TRAY (TRIPLE-LUMEN)(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: 8441424
• Report Number: 3006260740-2019-00615
• Device Sequence Number: 3057596
• Product Code: LJS
• UDI-Device Identifier: 00801741028441
• UDI-Public: (01)00801741028441
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

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: 3396118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1