MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G 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); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2024
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 evaluate.Results are expected soon.
Event or Problem Description
It was reported, "midline catheter broke off in patient vein during insertion attempt.Nurse attempting to insert a 20g 10cm midline in the patients right cephalic.On ultrasound, the tip of the needle started to hit the bottom of the vein while advancing.The catheter was not completely advanced to the hub of the needle.Nurse pulled the needle back slightly so the needle was in the center of the vein.About half of the needle was in.Nurse advanced the guidewire without issue or resistance.Nurse went to advance the catheter and as they were advancing there started to be resistance and nurse could see the catheter start curling under the skin.Nurse stopped and withdrew the catheter back.It started bleeding from the insertion site with the needle and guidewire still in.Nurse pulled out guidewire and then the needle and noticed part of the catheter was missing.Nurse held pressure, kept tourniquet on arm until physician could assess situation.Looked with ultrasound and could see the piece of catheter stuck in the patients vein.".
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 break in the catheter is confirmed and was determined to be use related.One 20 ga powerglide pro was returned for evaluation.An initial visual observation showed blood use residues throughout the returned powerglide pro.The returned device was returned fully assembled with a break in the catheter.The distal portion of the catheter was not returned for evaluation.About 7.5 cm of the catheter was returned attached to the device.A microscopic observation revealed granular fracture surface and sharp fracture edges of the split in the catheter.The observed characteristics of the split are typically caused by pulling the catheter back against the needle bevel during the insertion process.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings in section h11.
Event or Problem Description
It was reported, "midline catheter broke off in patient vein during insertion attempt.Nurse attempting to insert a 20g 10cm midline in the patients right cephalic.On ultrasound, the tip of the needle started to hit the bottom of the vein while advancing.The catheter was not completely advanced to the hub of the needle.Nurse pulled the needle back slightly so the needle was in the center of the vein.About half of the needle was in.Nurse advanced the guidewire without issue or resistance.Nurse went to advance the catheter and as they were advancing there started to be resistance and nurse could see the catheter start curling under the skin.Nurse stopped and withdrew the catheter back.It started bleeding from the insertion site with the needle and guidewire still in.Nurse pulled out guidewire and then the needle and noticed part of the catheter was missing.Nurse held pressure, kept tourniquet on arm until physician could assess situation.Looked with ultrasound and could see the piece of catheter stuck in the patients vein".

• Brand Name: FULL KIT 20G 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: 19056175
• Report Number: 3006260740-2024-01508
• Device Sequence Number: 17888881
• Product Code: FOZ
• UDI-Device Identifier: 00801741140686
• UDI-Public: (01)00801741140686
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 05/08/2024

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: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: F320108PT
• Device Lot Number: REHS1545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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 Age: 69 YR
• Patient Sex: Unknown