MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (18G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch "during a midline catheter placement, the vein was accessed, however, the catheter was unable to be successfully threaded over the device's guide wire.The procedure was stopped and the device was withdrawn.Upon removal and inspection of the midline device, the guidewire was not present or attached to the device.X-ray obtained and revealed the presence of foreign body to the left lower calf.Patient was taken to the operating room for foreign body removal." additional information received 09/27/2022: were all the missing pieces retrieved and accounted for? yes.
Additional Manufacturer Narrative
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 is pending evaluation.Results are expected soon.A lot history review (lhr) of regq1489 showed no other similar product complaint(s) from this lot number.
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, 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 midline catheter was confirmed.The product returned for evaluation was one 18ga powerglide pro rt midline catheter.The returned sample comprised a segment of catheter shaft approximately 2cm long.The fragment included the distal tip.The proximal catheter segment, including the luer adapter was not returned.Usage residues were observed throughout the sample.The break exhibited a tapered profile.Microscopic inspection of the break confirmed a tapered profile.The break surface was partially granular and partially glossy.Microscopic inspection of the catheter revealed folding and buckling of the distal tip.Material discoloration was observed in the vicinity of the deformation.The catheter break features were consistent with damage initiated by contact between the catheter shaft and the needle tip.Such damage can occur if the catheter is withdrawn or if the needle is reinserted following catheter advancement.The catheter tip deformation suggested that insertion against resistance, such as into tissue, likely contributed.
Event or Problem Description
It was reported via medwatch "during a midline catheter placement, the vein was accessed, however, the catheter was unable to be successfully threaded over the device's guide wire.The procedure was stopped and the device was withdrawn.Upon removal and inspection of the midline device, the guidewire was not present or attached to the device.X-ray obtained and revealed the presence of foreign body to the left lower calf.Patient was taken to the operating room for foreign body removal." additional information received 09/27/2022: were all the missing pieces retrieved and accounted for? yes.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (18G) (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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15505333
• Report Number: 3006260740-2022-03811
• Device Sequence Number: 7848510
• Product Code: FOZ
• UDI-Device Identifier: 00801741142642
• UDI-Public: (01)00801741142642
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: F118080T
• Device Lot Number: REGQ1489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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