MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (22G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	F122080T
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that during placement, guidewire went in smoothly.When clinician went to thread the catheter off of the needle, they felt resistance.They pulled the catheter back and then pulled back the guidewire with the purple advancer.When they pulled the whole device out of the patient, they noticed the guidewire was bent.As they were looking at the guidewire, they noticed that it looked unraveled and it then just fell off onto the ground.Patient had to be re-stuck.Second insertion was successful.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 manufacturer has received the sample and will evaluate.Results are expected soon.
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 complaint of a damaged guidewire is confirmed; however, the exact cause is unknown.One photograph of a guidewire was returned for evaluation.An initial visual observation of the photograph showed a guidewire detached from the powerglide device.The guidewire was observed to be unraveled indicating the core wire was broken.No use residue or other details of the damage could be discerned in the returned photograph.While the exact cause of the observed damaged guidewire could not be determined from the returned photograph, possible causes of the damaged guidewire include inadvertently advancing guidewire into tissue, advancing/withdrawing against resistance, and excessive tensile (pulling) force.H3 other text : evaluation findings are in section h11.
Event or Problem Description
Customer reported that during placement, guidewire went in smoothly.When clinician went to thread the catheter off of the needle, they felt resistance.They pulled the catheter back and then pulled back the guidewire with the purple advancer.When they pulled the whole device out of the patient, they noticed the guidewire was bent.As they were looking at the guidewire, they noticed that it looked unraveled, and it then just fell off onto the ground.Patient had to be re-stuck.Second insertion was successful.Additional info received on 17-jul-2023: no pieces retained in the patient.There was no patient harm.
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.
Event or Problem Description
Customer reported that during placement, guidewire went in smoothly.When clinician went to thread the catheter off of the needle, they felt resistance.They pulled the catheter back and then pulled back the guidewire with the purple advancer.When they pulled the whole device out of the patient, they noticed the guidewire was bent.As they were looking at the guidewire, they noticed that it looked unraveled, and it then just fell off onto the ground.Patient had to be re-stuck.Second insertion was successful.Additional info received on 17-jul-2023: no pieces retained in the patient.There was no patient harm.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (22G) (8CM)
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17182606
• Report Number: 3006260740-2023-02555
• Device Sequence Number: 15050893
• Product Code: FOZ
• UDI-Device Identifier: 00801741142680
• UDI-Public: (01)00801741142680
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2023

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: 01/31/2024
• Device Catalogue Number: F122080T
• Device Lot Number: REGT1968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 07/27/2023; 10/27/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 08/07/2023; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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 Sex: Unknown