MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F DL 3CG; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	CK000188C
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of 16tb6747 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
On (b)(6) 2016 - facility reported to the sales representative that during insertion of the picc, the red wing broke when tearing away the introducer in the dual lumen kit.No patient injury 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 detached tab on the 5fr microintroducer was inconclusive since the original complaint sample was not returned for investigation.One unopened kit was returned for investigation.A visual observation of the introducer revealed nothing remarkable.A microscopic examination of the returned unused sample revealed that a portion of the sheath edge was protruding from the unsplit molded wings.It appears that either the sheath was not centered when the tabs were molded or the tack hole was not centered in each half of the sheath.The complaint of ¿the red wing broke¿ was unconfirmed, a functional test and was observed that conducted the skiving at the top of the handles, this is made at the manufacturing line to help to break/split the handles; the handles were able to break clean.The problem could not be reproduced.

• Brand Name: POWERPICC 5F DL 3CG
• 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: 6152763
• Report Number: 3006260740-2016-00653
• Device Sequence Number: 10776436
• Product Code: LJS
• UDI-Device Identifier: 00801741101854
• UDI-Public: (01)00801741101854(17)171231(10)16TB6747
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K091234
• 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): 11/15/2016

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: 12/31/2017
• Device Catalogue Number: CK000188C
• Device Lot Number: 16TB6747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• 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: 12/07/2016
• Supplement Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1