MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE SCRUB IPA STERILE; PAD, ALCOHOL, DEVICE DISINFECTANT

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of judnf778 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the site-scrub was dry.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a dry sitescrub device is inconclusive due to the state the samples were returned in.Forty-four sitescrub ipa devices were returned for evaluation.An initial visual observation showed two of the returned samples were returned opened and forty-two of the samples were returned sealed.The two samples that were returned opened were found to be dry and the forty-two other samples that were returned sealed were all found to be wet.Because the two samples that were found to be dry were returned opened, it was not possible to determine if the dry state the devices were returned in was caused by damage to the device during storage, handling, or use or due to insufficient solution application during manufacture.
Event or Problem Description
It was reported that the site-scrub was dry.

• Brand Name: SITE SCRUB IPA STERILE
• Common Device Name: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8802364
• Report Number: 3006260740-2019-02009
• Device Sequence Number: 327450
• Product Code: LKB
• UDI-Device Identifier: 10801741086943
• UDI-Public: (01)10801741086943
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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 Model Number: N/A
• Device Catalogue Number: 3882100
• Device Lot Number: JUDNF778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1