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

Catalog Number	S02020-10
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2018
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 device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of asbts0143 showed one other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that during the internal inspection, one device unit was with an unidentified colorless material blocking the infusion tube.The device was not used on patient.
Event or Problem Description
It was reported that during the internal inspection, one device unit was with an unidentified colorless material blocking the infusion tube.The device was not used on patient.
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 material within the extension set tube is confirmed as supplier related.One 20 ga x 1 in miniloc safety infusion set was returned for investigation.The protective sheath was present over the needle.The safety mechanism was not activated.Fluid was observed within the tubing.The fluid observed within the tubing is likely to be silicone oil used in the manufacturing process.The sample was flushed with water using a 12 ml syringe and was found to be patent to infusion.A non-complainant wire was passed through the extension tubing and no obstructions were observed.The fluid observed within the extension tubing appeared to correspond to the material described in the event description and is likely silicone oil; therefore, the complaint is confirmed.The supplier has been notified of this event.A lot history review (lhr) of asbts0143 showed one other similar product complaint(s) from this lot number.

• 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: 7852958
• Report Number: 3006260740-2018-02367
• Device Sequence Number: 1633287
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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 Catalogue Number: S02020-10
• Device Lot Number: ASBTS0143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1