MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR SL POWERPICC SOLO CATHETER, BASIC; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	3194118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2016
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 to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rezk1919 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
Nurse reported that a patient was scheduled to receive chemotherapy treatment.The nurse was unable to get blood return at initial assessment and the patient complained of pain just above the insertion site.The patient was sent to another facility for further assessment and it was reported that leaking was noted escaping from the exit site from the patient.Nurse reported that the picc removed by 1 cm and a hole was noted (hole found in picc line at ~ the 7cm mark).The picc was removed.The patient missed the chemotherapy treatment but no patient injury was reported.
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 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 catheter leak was confirmed and the cause appears to be use related.The product returned for evaluation was a 4fr s/l powerpicc solo catheter.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated and a split was observed 0.1" distal to the 7cm depth marking.The catheter split was typical of flexural fatigue, and the characteristics observed which supported this type of failure included: damage which was circumferentially aligned; fracture edges which were rounded and polished due to repeated material wear; 'c' shaped impressions leading into the fracture site which are consistent with material buckling due to movement which caused the fracture edges to be pressed together; overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing).An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.

• Brand Name: 4 FR SL POWERPICC SOLO CATHETER, BASIC
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6181360
• Report Number: 3006260740-2016-00681
• Device Sequence Number: 19100263
• Product Code: LJS
• UDI-Device Identifier: 00801741027741
• UDI-Public: (01)00801741027741(17)170528(10)REZK1919
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2016

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 Expiration Date: 05/28/2017
• Device Catalogue Number: 3194118
• Device Lot Number: REZK1919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1