MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX PORT ACCESS KIT 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2142075
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recs0395 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the nurse noticed the hair in the package before accessing the patient.The kit was never opened.
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 hair in the packaging is confirmed and was determined to be manufacturing related.One powerloc max port access kit was returned for evaluation.An initial visual observation showed a hair within the sealed kit, between the kit packaging and its components.A lot history review (lhr) of recs0395 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the nurse noticed the hair in the package before accessing the patient.The kit was never opened.

• Brand Name: POWERLOC MAX PORT ACCESS KIT 20G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7792035
• Report Number: 3006260740-2018-02090
• Device Sequence Number: 1536295
• Product Code: FPA
• UDI-Device Identifier: 00801741044298
• UDI-Public: (01)00801741044298
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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 Expiration Date: 10/31/2019
• Device Model Number: 2142075
• Device Catalogue Number: 2142075
• Device Lot Number: RECS0395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1