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 Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that needle cracked at the level of the wings.It was stated that a leak occurred due to the crack at the wings.
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is invalid.
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), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a crack is confirmed; however, the exact cause is unknown.One 20 g x 0.6 in.Ez huber infusion set was returned for evaluation.An initial visual observation showed use residue on the returned sample.The returned sample was flushed and pressurized with a 12 ml syringe of water.The infusion set was found to be patent to infusion and aspiration and no leaks were found.The returned sample was also flushed and pressurized with water containing a colorant, but no leaks were found.A microscopic observation revealed superficial cracks within the material of the needle housing.No leakage was observed emanating from these cracks and a raking light indicated they did not reach the surface of the housing.Two small cracks were also observed on the surface of the top of the needle housing; however, no leakage was observed from these cracks either.While cracks were observed within the housing of the returned infusion set, no leaks were found.The cause of these cracks could not be determined from the returned sample; however, possible causes include over-pressurization, environmental conditions during storage or use, and exposure to incompatible chemicals.A lot history review (lhr) of refq4947 showed no other similar product complaint(s) from this lot number.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that needle cracked at the level of the wings.It was stated that a leak occurred due to the crack at the wings.

• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13726729
• Report Number: 3006260740-2022-00708
• Device Sequence Number: 17562437
• Product Code: FPA
• UDI-Device Identifier: 00801741089671
• UDI-Public: (01)00801741089671
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2022

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: REFQ4947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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