MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
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 foreign material in the device packaging was inconclusive because no sample was returned to vad for evaluation.Based on the description of the reported event, possible contributing factors include contamination of the kit before or after it was sealed; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time and the reported event could not be confirmed as a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of asaxs0117 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported hair inside the sealed package, making the material impossible to use.
Event or Problem Description
It was reported hair inside the sealed package, making the material impossible to use.
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 present within the packaging is confirmed to be supplier related.One sealed miniloc 20 ga x 1 in infusion set was returned for investigation.The product number and lot number on the packaging were ref: s02020-10 and lot: asaxs0117.A blue circle was observed to be marked on the clear packaging.A hair was observed to be present within the sealed sample.The supplier has been notified of this event.
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 foreign material in the device packaging was inconclusive because no sample was returned to vad for evaluation.Based on the description of the reported event, possible contributing factors include contamination of the kit before or after it was sealed; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time and the reported event could not be confirmed as a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of asaxs0117 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported hair inside the sealed package, making the material impossible to use.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8076138
• Report Number: 3006260740-2018-03234
• Device Sequence Number: 1569976
• Product Code: FPA
• UDI-Device Identifier: 00801741048722
• UDI-Public: (01)00801741048722
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2019

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: S02020-10
• Device Lot Number: ASAXS0117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 01/03/2019; 01/23/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 01/07/2019; 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1