MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER 4F FULL TRAY (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3274108
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 leaking catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr s/l powerpicc sv catheter.Usage residues were observed throughout the sample.A longitudinally aligned split was observed near the 6cm depth marking.An attempt to infuse water through the sample using a 12ml syringe revealed the white-luered lumen to be patent o infusion and aspiration with no observed leaks.During attempted infusion through the red-luered lumen, a spraying leak was observed emanating from the site of the aforementioned split.The catheter was fully occluded by blood products distal of the split.Tactile inspection of the sample revealed tensile weakness in the vicinity of the split.Microscopic inspection of the split revealed sharply defined granular edges.Material deformation and discoloration were observed in the vicinity of the split.The split characteristics, material deformation and tensile weakness were consistent with burst damage secondary to over-pressurization.The complete blood product occlusion suggested that attempted infusion of an occluded catheter may have contributed to the observed damage.The product ifu states ¿catheters that present resistance to flushing and aspiration may be partially or completely occluded.Do not flush against resistance.If the lumen will neither flush nor aspirate and it has been determined that the catheter is occluded with blood, a declotting procedure per institution protocol may be appropriate.¿ a lot history review (lhr) of recs1678 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the picc was placed in the left upper arm, left basilica vein with 3cm external length.The catheter was secured with securacath.It was stated that the vascular access team notified that the picc was leaking, dressing saturated.The dressing was removed, line was flushed, and leakage was noted from insertion site.The catheter was removed and upon flushing, noted to be leaking near the 7cm mark.A peripheral iv was placed, and a new picc inserted the following day.

• Brand Name: POWERPICC SV CATHETER 4F FULL TRAY (DUAL-LUMEN)
• 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: 8029170
• Report Number: 3006260740-2018-03076
• Device Sequence Number: 1435492
• Product Code: LJS
• UDI-Device Identifier: 00801741027826
• UDI-Public: (01)00801741027826
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

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: 3274108
• Device Catalogue Number: 3274108
• Device Lot Number: RECS1678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 36