MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET WITH INJECTIBLE SITE 20G X 1.5IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	0603300
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported the needle disconnected from the base with fixing fins.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached needle is confirmed; however, the exact cause is unknown.One 20 g x 1.5 in.Winged infusion set with a y-site without any packaging, five sealed 20 g x 1.5 in.Winged infusion sets, and one sealed 20 g x 1 in.Winged infusion set were returned for evaluation.An initial visual observation showed use residue on the sample returned without any packaging and the needle of this sample was observed to be completely detached from the housing.A microscopic observation of the detached needle revealed no adhesive on the needle cannula; however, adhesive was observed within the needle housing.The distal tip and the edge of the proximal end of the needle were observed to be damaged.The needle of each sample returned in a sealed package was found to be firmly attached within their respective needle housings.While the needle of the infusion set returned outside of any packaging was found to be completely detached from its housing, the cause of this condition is unknown.Possible causes include excessive force applied to the needle or housing during use, excessive manipulation of infusion set while inserted, and exposure to incompatible chemicals.
Event or Problem Description
It was reported the needle disconnected from the base with fixing fins.

• Brand Name: WINGED INFUSION SET WITH INJECTIBLE SITE 20G X 1.5IN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10371115
• Report Number: 3006260740-2020-02787
• Device Sequence Number: 3094815
• Product Code: FMI
• UDI-Device Identifier: 00801741065811
• UDI-Public: (01)00801741065811
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K863606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: 0603300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1