MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/21/2017
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 rebq0526 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.The probe covers were not used.
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 inconclusive due to the sample condition.One probe cover was returned for investigation.The cover had not been unfolded from its manufactured state.A black circle had been drawn in the corner of the folded cover.No foreign material was observed in the circle or on the cover.Holding the probe cover in the light revealed variation in the probe cover translucence within the circle.It is possible that the material existed on the probe cover, but the condition of the returned sample prevented confirmation of the reported event.The complaint sample was forwarded to the manufacturing facility for further review.(b)(4) evaluation: the complaint due to ¿foreign material in probe cover¿ was inconclusive.The visual inspection did not determine the origin of the foreign material on the bag.Due poor sample condition the cause of this complaint is inconclusive.A lot history review (lhr) of rebq0526 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.The probe covers were not used.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 6866363
• Report Number: 3006260740-2017-01619
• Device Sequence Number: 13758532
• 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: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: CK000290B
• Device Lot Number: REBQ0526
• 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: 08/30/2017
• 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