MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refz1120 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by rn," when placing the midline on (b)(6) 2022 the safety mechanism on the bard midline failed to stay in place properly.Usually once you thread the guidewire and then slide the catheter over top, as you are pulling the needle out it catches on a safety mechanism to enclose the sharp.Instead this time as i pulled the needle out the safety mechanism slid off the end of the needle and over the guidewire, falling onto the bed, leaving the needle exposed.".
Event or Problem Description
It was reported by rn," when placing the midline on (b)(6) 2022 the safety mechanism on the bard midline failed to stay in place properly.Usually once you thread the guidewire and then slide the catheter over top, as you are pulling the needle out it catches on a safety mechanism to enclose the sharp.Instead this time as i pulled the needle out the safety mechanism slid off the end of the needle and over the guidewire, falling onto the bed, leaving the needle exposed.".
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 safety mechanism failure was confirmed; however, the root cause was not identified.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and was not returned for evaluation.The safety mechanism was fully detached from the needle shaft and was received loose.The safety cannister was full of blood product residues.Microscopic inspection of the guidewire revealed a coil misalignment near the weld tip.The wire was intact.Inspection of the needle shaft revealed a region of increased luster at the flash notch.Following disassembly of the safety cannister, inspection of the binding clip revealed it to appear well formed.The red plastic retaining ring was fracture and was out of place.Inspection of the fracture revealed a granular fracture surface.The damaged plastic ring appeared to have contributed to the binding clip failing to cause the safety cannister to remain over the needle tip; however, it could not be determined if the ring was damaged during device use or during device assembly.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.

• Brand Name: FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: 14962287
• Report Number: 3006260740-2022-02618
• Device Sequence Number: 5395416
• Product Code: FOZ
• UDI-Device Identifier: 00801741140563
• UDI-Public: (01)00801741140563
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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 Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: F118108PT
• Device Lot Number: REFZ1120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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 Age: 73 YR
• Patient Sex: Unknown