MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 4F NURSE BASIC TRAY (SINGLE-LUMEN) (WITH MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3194118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2018
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 device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of reby0147 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reby0147) have been reported from the same canda facility.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that the picc was occluded at first attempt to use.The total catheter length was53 cm with external length of 9 cm.Reported by nursing staff that treated with cathflo on (b)(6) with no effect.Cxray done with change in tip position noted.No change in external length.Picc removed and noted memory of kink at 14cm mark (part that was inside patient).
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 catheter kink, which contributed towards an occlusion, was confirmed and was determined to be use related.The product returned for evaluation was a 4fr s/l powerpicc solo catheter.The sample contained blood and usage residue throughout and two permanent kink impressions were seen in the catheter shaft: one between the 10cm -11cm, and one between the 17cm-18cm depth markings.The catheter tubing was microscopically examined in, and around, the kink regions and no potential tubing defect or deficiency was observed.A segment of catheter tubing was taken near the 13cm depth marking and measured for dimensional conformity.The inside and outside diameters were measured to be within specification.The kink impressions appeared to have occurred during use and can be mitigated by placing the catheter in regions which are not prone to kinking.A lot history review (lhr) of reby0147 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reby0147) have been reported from the same (b)(6) facility.
Event or Problem Description
It was reported that the picc was occluded at first attempt to use.The total catheter length was53 cm with external length of 9 cm.Reported by nursing staff that treated with cathflo on mar 23 with no effect.Cxray done with change in tip position noted.No change in external length.Picc removed and noted memory of kink at 14cm mark (part that was inside patient).

• Brand Name: POWERPICC SOLO CATHETER 4F NURSE BASIC TRAY (SINGLE-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: 7466752
• Report Number: 3006260740-2018-00816
• Device Sequence Number: 18864153
• Product Code: LJS
• UDI-Device Identifier: 00801741027741
• UDI-Public: (01)00801741027741
• 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
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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: 3194118
• Device Catalogue Number: 3194118
• Device Lot Number: REBY0147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1