MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 4F; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 rezh1808 showed two other similar product complaint(s) from this lot number.Both complaints for this lot number (rezh1808) have been reported from the same (b)(4) facility.

Event Description

It was reported that the picc was inserted in the right upper brachial vein; 43 cm in total with 4 cm left out.It was stated that a securacath was used and a kink was found at 7 cm mark which was 3 cm inside the patient.Blood was drawn from the picc and flushed afterward.After flushing saline was reported to be leaking and the picc was removed.The patient will be having a further picc placed.

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 leaking catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr s/l powerpicc solo catheter.Usage residues were abundant throughout the sample.The depth markings were partially worn between the 3cm and 11cm depth markings.A partially circumferential split was observed between the 7cm and 8cm depth markings.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a leak was observed emanating from the site of the aforementioned split.The sample kinked easily and preferentially in the vicinity of the split during manual manipulation.Microscopic inspection of the split revealed inward curving edges.Material buckling and material abrasion were visible in the vicinity of the split.A longitudinally aligned split was observed at one corner of the split.The catheter exhibited an elliptical cross-section in the vicinity of the split.The split characteristics and surrounding features were 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.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 4F
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 6214441
• MDR Text Key: 63812942
• Report Number: 3006260740-2016-00709
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Public: (01)(17)170228(10)REZH1808
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 2194108
• Device Lot Number: REZH1808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1