MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK PATIENT TUBING

Catalog Number	70PH
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the patient got an infection from the patient hose due to sediment build up between the over sleeve and the hose.Per additional information received via phone from the customer contact on (b)(6) 2020, the patient hose was changed within 30 days of use and the patient's infection was treatment with antibiotics via injections.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause will be added to the design failure mode and effect analysis.A labeling review was not completed as the user would not likely cause the reported issue.
Event or Problem Description
It was reported that the patient got an infection from the patient hose due to sediment build up between the over sleeve and the hose.Per additional information received via phone from the customer contact on 25feb2020, the patient hose was changed within 30 days of use and the patient's infection was treatment with antibiotics via injections.

• Brand Name: PUREWICK PATIENT TUBING
• Common Device Name: PUREWICK PATIENT TUBING
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9780677
• Report Number: 1018233-2020-01498
• Device Sequence Number: 11390927
• Product Code: NZU
• UDI-Device Identifier: 00801741151811
• UDI-Public: (01)00801741151811
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 70PH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 04/12/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention