MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 19G X 25MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	SHG19-100
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reer1219 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported leak was noted at the luer lock connection point.The users also found that if a 3-way valve is installed between the cannula and the infusion line, there is no longer any leakage.No other information was provided.
Event or Problem Description
It was reported leak was noted at the luer lock connection point.The users also found that if a 3-way valve is installed between the cannula and the infusion line, there is no longer any leakage.No other information was provided.
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, 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 a damaged luer adapter was confirmed.The product returned for evaluation was two 19ga x 1¿ ez huber safety infusion sets.The first sample (sample 1) exhibited use residues throughout.The safety was engaged and a cap was attached to the luer adapter.The second sample (sample 2) was received in its original sealed packaging.Attempts to infuse water through both samples using a 12ml syringe revealed both to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (>15 seconds) hydraulic pressurization.Microscopic inspection of sample 1 revealed superficial stress fractures throughout the luer adapter.Microscopic inspection of sample 2 was unremarkable.Both luer adapters were inspected using an iso taper gauge and sample 1 exhibited an out of spec luer.Sample 2 was unremarkable.While no leaks were identified, the too large luer orifice exhibited by sample 1 suggested that leaking may have occurred during use with other accessories.The stress fracturing suggested that forceful insertion of a tapered object, such as a slip-fit luer accessory likely caused/contributed to the luer damage.Sample 2 was unused, undamaged and appeared to have been returned as an unused lot sample.

• Brand Name: EZ HUBER 19G X 25MM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11605452
• Report Number: 3006260740-2021-01081
• Device Sequence Number: 3261950
• Product Code: FPA
• UDI-Device Identifier: 00801741089077
• UDI-Public: (01)00801741089077
• 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): 05/17/2021

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 Model Number: SHG19-100
• Device Catalogue Number: SHG19-100
• Device Lot Number: REER1219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other