MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROV 4F DL IR 135CM NI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	S3274335
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 device has not been returned to the manufacturer, at this time, for evaluation.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 the patient had a double lumen power picc placed at ir.The patient was referred back to ir for picc replacement as it was reported that one lumen was completely broken and a second lumen was leaking.The picc was replaced.No patient injury reported.
Event or Problem Description
It was reported that the patient had a double lumen power picc placed at ir.The patient was referred back to ir for picc replacement as it was reported that one lumen was completely broken and a second lumen was leaking.The picc was replaced.No patient injury reported.
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 break is confirmed.One 4 fr dual lumen power picc provena was returned for evaluation.An initial visual observation showed the purple luer hub was missing.Use residue was observed throughout the sample and some dressing or securement material was observed on the purple lumen.The pinch clamp on the purple lumen was observed to be engaged, and the ink on the extension legs was observed to be worn and faded.A microscopic observation revealed the fracture surface of the extension tubing of the purple lumen was rough and exhibited cracks/fissures and beach marks.Two holes were observed in the extension tubing of the red lumen, just within the luer hub.Cracks/fissures and beach marks were observed on these fracture surfaces as well.

• Brand Name: PROV 4F DL IR 135CM NI
• 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: 7401389
• Report Number: 3006260740-2018-00624
• Device Sequence Number: 1146891
• Product Code: LJS
• UDI-Device Identifier: 00801741130045
• UDI-Public: (01)00801741130045
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019
• Report Date (Section F): 03/14/2018

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: S3274335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR