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	02/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "the insertion of the catheter "felt funky - worked fine but safety didn't deploy - it's still up in the housing.".
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A batch history review (bhr) of regx2912 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer that "the insertion of the catheter "felt funky - worked fine but safety didn't deploy - it's still up in the housing." no other information was provided.Additional information received: placed a power glide, and when pulling back on the housing to disengage from the device, the safety did not cover needle, it stayed in housing.".
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: sample analysis, patient severity, applicable previous investigation(s), complaint and lot history review, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of safety mechanism failure to advance was confirmed; however, the root cause was not identified.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.The catheter had been advanced and was not returned for evaluation.The catheter advancer wings were also not returned.The safety remained at the base of the needle shaft and was not engaged over the needle tip.Microscopic inspection of the needle shaft and the safety mechanism was unremarkable.An attempt to advance the safety mechanism was successful and unremarkable.No resistance was encountered when advancing the safety and it secured over the needle tip as intended.The safety mechanism failed to advance with the catheter as intended; however, no resistance was encountered when advancing the safety during sample evaluation.These observations suggested that the safety was not properly engaged with the catheter advancer prior to catheter placement; however, the advancer itself was not available for inspection and no other evidence was observed to inform how the safety mechanism and catheter advancer became detached.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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16475509
• Report Number: 3006260740-2023-00632
• Device Sequence Number: 7325528
• Product Code: FOZ
• UDI-Device Identifier: 00801741140563
• UDI-Public: (01)00801741140563
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: F118108PT
• Device Lot Number: REGX2912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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: 84 YR
• Patient Sex: Female