MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV ULTRA PED CATHETER RETAINER, ULTRA PEDIATRIC PADS 50 BOX; STAND, INFUSION

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 judnf007 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there was a hair inside the packaging.The device was not used a patient.
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), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a foreign material inside the packaging of a statlock kit is confirmed and was determined to be manufacturing related.One iv ultra pediatric statlock kit was returned for evaluation.An initial visual observation showed the kit was returned sealed and a short, dark fiber was observed within the kit.The fiber was observed to be loose in the packaging with no interference with the packaging¿s seal area.An awareness training was conducted by the manufacture site.A lot history review (lhr) of judnf007 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there was a hair inside the packaging.The device was not used a patient.

• Brand Name: STATLOCK IV ULTRA PED CATHETER RETAINER, ULTRA PEDIATRIC PADS 50 BOX
• Common Device Name: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8722099
• Report Number: 3006260740-2019-01715
• Device Sequence Number: 1685268
• Product Code: FOX
• UDI-Device Identifier: 00801741081750
• UDI-Public: (01)00801741081750
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: IV0500
• Device Lot Number: JUDNF007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1