MAUDE Adverse Event Report: ADAPTEC MEDICAL DEVICES LLC 3014271001 PATIENT TUBING FOR USE WITH DRYDOC VACUUM STATION

Catalog Number	70PH
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Bacterial Infection (1735); 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.The device was not returned.
Event or Problem Description
It was reported that the patient experienced a bacterial growth inside of the patient tubing that has made the patient sick.The patient's doctor alleged that the bacterial growth caused a bacteria infection.It is unknown what medical interventions were given for the infection.
Event or Problem Description
It was reported that the patient experienced a bacterial growth inside of the patient tubing that has made the patient sick.The patient's doctor alleged that the bacterial growth caused a bacteria infection.It is unknown what medical interventions were given for the infection.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to ¿inadequate material selection - materials of construction are not biocompatible¿.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "perform perineal care and assess skin integrity" and "replace the purewicktm female external catheter at least every 8-12 hours or if soiled with feces or blood".H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• Brand Name: PATIENT TUBING FOR USE WITH DRYDOC VACUUM STATION
• Common Device Name: PATIENT TUBING
• Manufacturer (Section D): ADAPTEC MEDICAL DEVICES LLC 3014271001; 260 james jackson avenue; cary NC 27513
• MDR Report Key: 9833027
• Report Number: 1018233-2020-01834
• Device Sequence Number: 3069543
• 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): 04/21/2020

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: 02/20/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 03/14/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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: Other