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

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2024

Event Type  Injury  

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 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.".

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 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
• Type of Device: 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
• MDR Text Key: 339551823
• Report Number: 3006260740-2024-01508
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140686
• UDI-Public: (01)00801741140686
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR