MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR SL POWERPICC SOLO CATHETER 70CM NITINOL; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	3194355
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/05/2016
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 malfunction with the 4 fr s/l powerpicc solo was unconfirmed.The reported malfunction was that the patient felt a pop.The returned catheter showed evidence of use, but no damage or defects were noted on the sample.The catheter tubing extended 12.6cm from the distal end of the molded wing.The printing was worn on one side of the winged hub.A tacky residue, which could be remnants from the dressing, was found on the extension leg.Kinks in the extension leg were found 1.5cm and 0.2cm from the distal end of the solo hub.The catheter tubing was kinked 8.7cm from the distal end of the molded wing.A functional test showed that the catheter was patent to infusion and no leaks were identified.A tactual investigation revealed nothing remarkable.It is unknown if the returned device is complete.It is unknown if any complications associated with the clinical setting affected the functional performance of the returned device.At this time, based on the evidence provided with the returned sample, it is unknown what caused the alleged event.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rezk0222 showed no other similar product complaint(s) from these lot numbers.
Event or Problem Description
It was reported by sales rep, patient had catheter placed.Once the catheter was placed the patient felt a pop.Catheter was removed, a new device was placed.
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.On 7/13/2016 - the initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred per 21 crf803.19.During investigation no damage or defects were noted on the sample.
Event or Problem Description
It was reported by sales rep, patient had catheter placed.Once the catheter was placed the patient felt a pop.Catheter was removed, a new device was placed.

• Brand Name: 4 FR SL POWERPICC SOLO CATHETER 70CM NITINOL
• 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: 5765052
• Report Number: 3006260740-2016-00306
• Device Sequence Number: 19123506
• Product Code: LJS
• UDI-Device Identifier: 00801741027789
• UDI-Public: (01)00801741027789(17)170528(10)REZK0222
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2016

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: 3194355
• Device Lot Number: REZK0222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2016
• Supplement Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR