MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 20G X 15MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reez3291 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that on withdrawing blood, leak discovered where port tubing meets hub.No harm to patient or staff.It was stated the needle removed and replaced with a new one.
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, 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 leak at the needle housing is confirmed but the exact cause remains unknown.One 20 ga ez huber infusion set was returned for evaluation.The product label returned indicated lot: reez3291.The safety mechanism was returned fully engaged over the needle tip.The infusion set was flushed with water and fluid was observed to leak at the clear plastic needle housing.Microscopic observation of the leak location revealed multiple horizontal cracks in the clear housing material.The cracks appeared to have propagated from the proximal end of the housing up to the region where the needle is located.The cracks also appeared to be aligned in the same region as the location of the extension tubing within the housing.Based on the condition of the returned sample, possible contributing factors include damage during storage and handling.Since the location at which the component may have been exposed to external stresses could not be determined, the complaint is confirmed but the exact cause remains unknown at this time.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that on withdrawing blood, leak discovered where port tubing meets hub.No harm to patient or staff.It was stated the needle removed and replaced with a new one.

• Brand Name: EZ HUBER 20G X 15MM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13374009
• Report Number: 3006260740-2022-00101
• Device Sequence Number: 5011110
• Product Code: FPA
• UDI-Device Identifier: 00801741089671
• UDI-Public: (01)00801741089671
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: SHN20-60
• Device Lot Number: REEZ3291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown