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

Catalog Number	CK0000102
Health Effect - Clinical Code	No Information (3190)
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 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 hair in the sterile field was inconclusive due to the sample condition.Returned for investigation was a plastic bag, which contained what appears to be a hair that was taped to the inside of the bag and against another sheet of plastic.The strand was approximately 5cm in length.The kit packaging and contents were not returned for investigation.It cannot be verified that the hair was contained in the packaged kit due to the condition of the evidence provided for investigation.A lot history review (lhr) of reat1916 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales representative, facility reported that when they were preparing for placement they noticed a hair in the sterile field.

• Brand Name: 5F SL POWERPICC 3CG, MB
• 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: 6332806
• Report Number: 3006260740-2017-00078
• Device Sequence Number: 19132633
• Product Code: LJS
• UDI-Device Identifier: 00801741036262
• UDI-Public: (01)00801741036262(17)171231(10)REAT1916
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2017

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: CK0000102
• Device Lot Number: REAT1916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1