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

Catalog Number	CK000290B
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebq1094 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the facility had a brownish colored sticky substance in with the probe covers.
Additional Manufacturer Narrative
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 brown colored sticky substance on the probe cover was confirmed and determined to be supplier related.One probe cover was returned for investigation with a gel packet.The cover had not been unfolded from its manufactured state.An orange colored sticky residue was observed between the lower left corner of the packet and the probe cover.The complaint sample was forwarded to the manufacturing facility for further review.(b)(4) evaluation: the complaint due to ¿brownish colored sticky substance in the probe covers¿ was confirmed.The visual inspection determined that gel pouch was opened on sealing part, causing gel output in order to determine cause of this as wrong sealing on gel pouch.Due to this the complaint is confirmed supplier related.The cause of this condition will be directed as supplier related.An incident report is performed to notify the supplier about this defect.A lot history review (lhr) of rebq1094 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the facility had a brownish colored sticky substance in with the probe covers.

• Brand Name: POWERPICC SOLO CATHETER, 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: 6866006
• Report Number: 3006260740-2017-01587
• Device Sequence Number: 16368389
• Product Code: LJS
• UDI-Device Identifier: 00801741132070
• UDI-Public: (01)00801741132070
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: 07/31/2018
• Device Catalogue Number: CK000290B
• Device Lot Number: REBQ1094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1