MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PPICC 4F SL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	CK000739
Health Effect - Clinical Code	No Patient Involvement (2645)
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 (b)(6) documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a hair in a kit is inconclusive, due to poor sample condition.One photograph of what appears to be the bottom of a kit tray was returned for evaluation.An initial visual observation of the photograph showed what appears to be a dark, curved hair on a paper measuring tape.It cannot be determined from the returned photograph if the hair is within or outside of the kit.It also cannot be determined from the returned photograph if the kit was opened or remains sealed.Due to these unknown conditions, it was not possible to confirm the complaint of a hair in a kit from the returned photograph.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that a hair was found in the sterile packaging.The device was not used on the patient.

• Brand Name: DOT PPICC 4F SL 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7234229
• Report Number: 3006260740-2018-00091
• Device Sequence Number: 1110363
• Product Code: LJS
• UDI-Device Identifier: 00801741139659
• UDI-Public: (01)00801741139659
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

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 Catalogue Number: CK000739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1