MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	Vasculitis (2004); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that, "the catheter was crimped/serrated indicating possible severance of the catheter.Ob rn initially reported edema, erythema, and hardness along basilic vein path both proximal and distal to insertion site with concern for both clot and phlebitis.Vat rn assessed site with ultrasound and found a non-occlusive clot in basilic vein extending to connection with brachial vein.Within the clot just distal to the brachial vein was a small white luminescent circular image.Writer retrieved removed catheter and noted the very end (1-2mm) was crimped/serrated indicating possible severance of the catheter.Removed catheter compared to another 18 g 10 cm bard powerglide.Despite the midlines being different lot numbers, the removed catheter's tip was slightly shorter compared to the unused catheter.A diagnostic venous ultrasound was performed to assess the rue and the ultrasound tech also noted the same small white luminescent circular image potentially consistent with a foreign body within the body of the non-occlusive clot." additional information received 25 march 2024: the patient had a thrombosis at the tip of catheter that resulted in a further thrombosis in her left upper basilic vein.The iv catheter was removed.Another rn felt that part of the tip may have been sheared off and in the blot clot.The catheter was found, assessed and compared to a fresh 18 ga 10 cm powerglide catheter.The tip was noted to be crimped a little bit.Aside from a occlusive thrombosis at the tip of catheter, pain and tenderness, and subsequent removal of the catheter, there was no serious complication related to the catheter.
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 device has not been returned to the manufacturer for evaluation.H3 other text: device not returned for evaluation.
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 deformation of a catheter is confirmed and was determined to be use related.One 10 cm catheter from an 18 ga powerglide pro was returned for evaluation.An initial visual observation revealed a break in the catheter towards the distal end of the catheter.The paper returned with the catheter clarifies the user pulled the intact catheter out of the trash and cut the catheter to observe it under a microscope.A kink was observed along the catheter shaft.A microscopic observation revealed significant deformation of the distal tip of the catheter.The catheter tip was folded in on itself with bent, rough edges at the distal tip of the catheter.The proximal end of the catheter and the distal end of the catheter were measured together using a steel ruler to reveal the returned length of the catheter was 10 cm.Because the length of the returned catheter segments were measured to be 10 cm, the entire catheter was returned with no missing catheter sections evident.Because of the observed deformation along the catheter shaft along with the details of the event, the complaint of deformation of the distal tip of the catheter is confirmed and was determined to be use related.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that, "the catheter was crimped/serrated indicating possible severance of the catheter.Ob rn initially reported edema, erythema, and hardness along basilic vein path both proximal and distal to insertion site with concern for both clot and phlebitis.Vat rn assessed site with ultrasound and found a non-occlusive clot in basilic vein extending to connection with brachial vein.Within the clot just distal to the brachial vein was a small white luminescent circular image.Writer retrieved removed catheter and noted the very end (1-2mm) was crimped/serrated indicating possible severance of the catheter.Removed catheter compared to another 18 g 10 cm bard powerglide.Despite the midlines being different lot numbers, the removed catheter's tip was slightly shorter compared to the unused catheter.A diagnostic venous ultrasound was performed to assess the rue and the ultrasound tech also noted the same small white luminescent circular image potentially consistent with a foreign body within the body of the non-occlusive clot." additional information received 25 march 2024: the patient had a thrombosis at the tip of catheter that resulted in a further thrombosis in her left upper basilic vein.The iv catheter was removed.Another rn felt that part of the tip may have been sheared off and in the blot clot.The catheter was found, assessed and compared to a fresh 18 ga 10 cm powerglide catheter.The tip was noted to be crimped a little bit.Aside from a occlusive thrombosis at the tip of catheter, pain and tenderness, and subsequent removal of the catheter, there was no serious complication related to the catheter.

• Brand Name: FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER
• 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: 19041808
• Report Number: 3006260740-2024-01458
• Device Sequence Number: 7270915
• Product Code: FOZ
• UDI-Device Identifier: 00801741140662
• UDI-Public: (01)00801741140662
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/05/2024

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: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F318108PT
• Device Lot Number: REHV1818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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