MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 22G X 25MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, "on (b)(6) 2022 at 15:00 i removed the 5 fu from the port needle and the twist lock from the port needle was broken from 2 sides, flushing of the port needle was not possible.Dha also looked at this and could not flush the port needle because everything was going on.Chemotherapy did not run concurrently.Rotational blockade was greater than with other infusions.".
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refs0939 showed no other similar product complaint(s) from this lot number.
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 damaged ez huber infusion set is inconclusive due to poor sample condition.One open ez huber 22 ga x 25 mm sample and twenty-two sealed samples were returned for evaluation.All of the sample packaging indicated lot: refs0939.The open sample was inspected.The white cap was able to be removed.Microscopic observations of the luer hub did not reveal any apparent damage or cracks.The sample was infused and pressurized with water using a 12 ml syringe and no leaks were experienced.The remaining sealed kits were opened and also inspected.No issues or damage were noted during microscopic observation and functional testing of the sealed samples.It could not be determined if the sample experiencing the reported issue was returned.Since none of the returned samples exhibited damage corresponding to the entry description of ¿needle was broken from 2 sides, flushing of the port needle was not possible¿, the complaint could not be confirmed and remains inconclusive at this time.
Event or Problem Description
It was reported, "on (b)(6) 2022 at 15:00 i removed the 5 fu from the port needle and the twist lock from the port needle was broken from 2 sides, flushing of the port needle was not possible.Dha also looked at this and could not flush the port needle because everything was going on.Chemotherapy did not run concurrently.Rotational blockade was greater than with other infusions.".

• Brand Name: EZ HUBER 22G 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
• 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: 14713994
• Report Number: 3006260740-2022-02285
• Device Sequence Number: 2235243
• Product Code: FPA
• UDI-Device Identifier: 00801741089268
• UDI-Public: (01)00801741089268
• 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: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

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: SHG22-100
• Device Lot Number: REFS0939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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