MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of foreign material on the infusion set needle was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a 22ga x 0.75¿ miniloc safety infusion set.The visible portion of the device included the needle housing, non-engaged safety mechanism and needle.No obvious usage residues were observed.Unidentified material was observed on the needle shaft, just proximal of the bevel.While unidentified material was evident in the submitted photograph, inspection of the photograph was insufficient to identify potential sources of the material.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include material deposition prior to device packaging and following device removal.A lot history review (lhr) of ascvs0065 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by patient that after taking off the needle cap, a piece of blue foam or gauze was noticed on the tip of the needle.Needle was not used or inserted into port.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a foreign material on the needle is confirmed and appears to be supplier related.One 22 ga x 0.75 in miniloc infusion set was returned for investigation.The sample was returned in open packaging indicating ref: s02022-75 and lot: ascvs0065.One photo sample of a 22 ga x 0.75 in miniloc infusion set was also returned.The photo appeared to correspond to the returned sample.The needle sleeve was present over the needle.The needle cover was removed.Microscopic observation of the needle shaft revealed a greenish material present.The material appears to be composed of thin structured links.The material present appears to resemble material used in the manufacturing process; therefore, the complaint is confirmed.The supplier has been notified of this event.A lot history review (lhr) of ascvs0065 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by patient that after taking off the needle cap, a piece of blue foam or gauze was noticed on the tip of the needle.Needle was not used or inserted into port.

• Brand Name: MINILOC SAFETY INFUSION SET 22G 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: 9234526
• Report Number: 3006260740-2019-03327
• Device Sequence Number: 14084536
• Product Code: FPA
• UDI-Device Identifier: 00801741048869
• UDI-Public: (01)00801741048869
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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 Expiration Date: 07/28/2021
• Device Model Number: N/A
• Device Catalogue Number: S02022-75
• Device Lot Number: ASCVS0065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Event Location: Home
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1