MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PG PRO 18G 10CM FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refy1539 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "at approximately 10:30 am today, (b)(6) 2022, there was an equipment issue with a midline device.Md attempted to insert a midline into patient.The device malfunctioned, dr called surgery to aid in the removal of the midline from patient, which was successful.No injury to patient; patient denies pain; va duplex of the affected limb ordered.We recovered the device.".
Event or Problem Description
It was reported "at approximately 10:30 am today, (b)(6) 2022, there was an equipment issue with a midline device.Md attempted to insert a midline into patient.The device malfunctioned, dr called surgery to aid in the removal of the midline from patient, which was successful.No injury to patient; patient denies pain; va duplex of the affected limb ordered.We recovered the device.".
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, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an equipment issue with a powerglide pro was confirmed but the cause is unknown.Three photographs were returned for evaluation.The 18g x 10cm powerglide pro contained residual material in the lumen of the catheter, indicating the device had been used.A guidewire fragment was visible in the photographs.The fragment contained a complete break in the inner core and outer coil wires.The coil wire on the guidewire was unraveled and elongated.It is possible that complications with device deployment contributed to the guidewire damage.Damage to the guidewire can occur if the guidewire is forced against the sharp edge of the needle bevel causing it to shear.However, without the physical sample, the device could not be microscopically examined, tactility evaluated, or dimensionally analyzed.Therefore, the exact root cause could not be determined.H3 other text: evaluation findings are in section h11.

• Brand Name: DOT PG PRO 18G 10CM FULL
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14053568
• Report Number: 3006260740-2022-01201
• Device Sequence Number: 11913013
• Product Code: FOZ
• UDI-Device Identifier: 00801741110665
• UDI-Public: (01)00801741110665
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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: N/A
• Device Catalogue Number: F218101
• Device Lot Number: REFY1539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: Required Intervention
• Patient Sex: Unknown