MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (20G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
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 be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that powerglide broke off into customer's vein during placement.Additional information received july 16, 2024: course of events: (b)(6) fractured catheter upon insertion.Vascular surgeon consulted.7/11/24 left humerus xray done.Exploration of left arm veins by md, unable to locate fragment of catheter.Cvc triple lumen right: placed by md (unable to use bue for vascular access: rue (+) for dvt, lue presence of catheter fragment on brachial veins 7/12/24 ct of left upper extremity without contrast: prescence of 1.8 linear hypodensity which could represent catheter fragment within the anterior arm soft tissues (b)(6) 2024 exploration of left arm removal of cephalic, basilic and brachial vein from antecubital fossae to axilla along with adjacent branches.Unable to locate.(b)(6) 2024 no further surgical intervention.Placed on comfort care measures.
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 broken powerglide is confirmed; however, the exact cause is unknown.Two photographs of a powerglide pro were returned for evaluation.An initial visual observation of one of the photographs showed two powerglide catheters of different lengths.About 2 cm of the catheter on the right appeared to be missing; however, no details of the break site could be discerned from the returned photograph.Use residue was observed on and within both catheters.There were no distinguishing features in the returned photographs of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that powerglide broke off into customer's vein during placement.Additional information received july 16, 2024: course of events: (b)(6) fractured catheter upon insertion.Vascular surgeon consulted.(b)(6) 2024 left humerus xray done.Exploration of left arm veins by md, unable to locate fragment of catheter.Cvc triple lumen right: placed by md (unable to use bue for vascular access: rue (+) for dvt, lue presence of catheter fragment on brachial veins.(b)(6) 2024 ct of left upper extremity without contrast: prescence of 1.8 linear hypodensity which could represent catheter fragment within the anterior arm soft tissues.(b)(6) 2024 exploration of left arm removal of cephalic, basilic and brachial vein from antecubital fossae to axilla along with adjacent branches.Unable to locate.(b)(6) 2024 no further surgical intervention.Placed on comfort care measures.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (20G) (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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19931968
• Report Number: 3006260740-2024-04289
• Device Sequence Number: 2781538
• Product Code: FOZ
• UDI-Device Identifier: 00801741142666
• UDI-Public: (01)00801741142666(11)240609(17)250930(10)REJR2037
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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 Expiration Date: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: F120080T
• Device Lot Number: REJR2037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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