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

Model Number	F118081
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reex1227 showed no similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "after deploying catheter into vein, wire sheared and remained in patient.It appears wire unraveled when attempting to remove.Removed wire from patient.Advised rn/md.Obtained xray of arm to determine if any wire remained in patient.".
Event or Problem Description
It was reported "after deploying catheter into vein, wire sheared and remained in patient.It appears wire unraveled when attempting to remove.Removed wire from patient.Advised rn/md.Obtained xray of arm to determine if any wire remained in patient.".
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 frayed guidewire is confirmed but the exact cause remains unknown.One 18 ga powerglide pro device was returned for evaluation.The product sticker label indicated lot: reex1227.The catheter was not returned with the device and the safety mechanism was successfully activated over the needle tip.Blood residue and evidence of use was present on the device.The guidewire was observed to be frayed and elongated.Microscopic observation of the core wire and coil wire did not reveal the weld tip to be present.The event description indicates fraying of the wire occurred during removal.Based on the information provided, retraction against resistance and damage against the needle bevel.Since the guidewire was observed to be frayed, the complaint is confirmed but the exact causing factors during use remain unknown.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER
• 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: 12314116
• Report Number: 3006260740-2021-03261
• Device Sequence Number: 17270078
• Product Code: FOZ
• UDI-Device Identifier: 00801741110559
• UDI-Public: (01)00801741110559
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: F118081
• Device Catalogue Number: F118081
• Device Lot Number: REEX1227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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: Required Intervention
• Patient Sex: Unknown