MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 20G X 25MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
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 rect0199 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the clamp on the device was leaking.The needle was placed 3 days prior.
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, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of fluid leaking past a pinch clamp is confirmed and was determined to be use related.Two 20 g x 1 in.Ez huber infusion sets were returned for evaluation.An initial visual observation showed one sample was returned in a sealed package and the other sample was returned without any packaging and appeared to have been used.The pinch clamp of the used sample was observed to be engaged on the extension tubing.An attempt was made to flush the used sample with a 12 ml syringe of water while the pinch clamp was engaged.Fluid was observed to pass through the location the tubing was clamped.The clamp was disengaged and repositioned multiple times, and the clamp was found to not fully occlude the tubing at any location.The pinch clamp of the sample that was returned in a sealed package was found to fully occlude the extension tubing.Once the pinch clamp of the used sample returned was disengaged, it could be seen that the radius of the hinge of the clamp nearest the barbed end was larger than usual.This was likely caused by over-extension of the hinge of the pinch clamp during disengagement of the clamp.A lot history review (lhr) of rect0199 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the clamp on the device was leaking.The needle was placed 3 days prior.

• Brand Name: EZ HUBER 20G X 25MM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9541046
• Report Number: 3006260740-2019-04035
• Device Sequence Number: 2340845
• Product Code: FPA
• UDI-Device Identifier: 00801741089169
• UDI-Public: (01)00801741089169
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

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: SHG20-100
• Device Lot Number: RECT0199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1