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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a damaged guidewire was confirmed.The product returned for evaluation was one 22ga x 8cm powerglide pro midline catheter assembly.The catheter had been advanced and the safety mechanism was engaged.Usage residues were observed throughout the sample.The guidewire exhibited a complete break just distal of the needle tip.The distal fragment was not returned.Microscopic inspection of the wire revealed the break to have occurred in the transition region.The break exhibited a granular fracture surface.Microscopic inspection of the needle revealed mechanical damage along the proximal edge of the bevel.The guidewire break features were consistent with tensile (pulling) damage.The needle bevel deformation indicated that retraction of the wire against the needle at a sharp angle likely initiated the wire damage.A lot history review (lhr) of reex1255 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the wire fell off when attempting to retract back into the housing.No other information provided.On (b)(6) 2021- the guidewire of the returned sample exhibited a complete break.

• Brand Name: DOT PG PRO 22G 8CM RT
• 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
• MDR Report Key: 12219700
• Report Number: 3006260740-2021-02946
• Device Sequence Number: 1390435
• Product Code: FOZ
• UDI-Device Identifier: 00801741152771
• UDI-Public: (01)00801741152771
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: F322088PTX
• Device Lot Number: REEX1255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other