MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 22G X 8 CM WITH BIOPATCH AND PROBE COVER; 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	10/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned.
Event or Problem Description
It was reported by the customer "the catheter broke off the hub at the patient's insertion site."at approximately 1200, this rn, attempted a midline insertion on the left upper basilic vessel in a sterile fashion.After deploying the guidewire, the catheter was threaded into the vein.When trying to remove the guidewire device, the catheter and needle would not release out of the vessel.The catheter sheared off at the level of the skin.Surgery was called to the bedside for evaluation." did the event result in any long-term harm (if yes, please describe), or did it result in a delay in treatment that had a negative impact on patient outcomes? delay in treatment and negative impact on patient.It was painful to remove.Was a new device successfully inserted for vascular access? no, we inserted a regular peripheral iv.If available, please provide the patient age, weight, diagnosis, and treatment needed.Pneumonia, antibiotics.Has the patient recovered? if no, please describe.The patient recovered from midline placement.Was a piece of the midline retained in the patient? if yes, was it successfully removed and by what means? the surgery team came and did a cut down to release the midline.The catheter broke off the hub at the patient's insertion site.Did the event result in any long-term harm (if yes, please describe), or did it result in a delay in treatment that had a negative impact on patient outcomes? delay in treatment and negative impact on patient.It was painful to remove.
Event or Problem Description
It was reported by the customer "the catheter broke off the hub at the patient's insertion site."at approximately 1200, this rn, attempted a midline insertion on the left upper basilic vessel in a sterile fashion.After deploying the guidewire, the catheter was threaded into the vein.When trying to remove the guidewire device, the catheter and needle would not release out of the vessel.The catheter sheared off at the level of the skin.Surgery was called to the bedside for evaluation." did the event result in any long-term harm (if yes, please describe), or did it result in a delay in treatment that had a negative impact on patient outcomes? delay in treatment and negative impact on patient.It was painful to remove.Was a new device successfully inserted for vascular access? no, we inserted a regular peripheral iv if available, please provide the patient age, weight, diagnosis, and treatment needed.Pneumonia, antibiotics has the patient recovered? if no, please describe.The patient recovered from midline placement.Was a piece of the midline retained in the patient? if yes, was it successfully removed and by what means? the surgery team came and did a cut down to release the midline.The catheter broke off the hub at the patient's insertion site.Did the event result in any long-term harm (if yes, please describe), or did it result in a delay in treatment that had a negative impact on patient outcomes? delay in treatment and negative impact on patient.It was painful to remove.
Additional Manufacturer Narrative
Initial medwatch report was submitted, upon further review it was found that this medwatch report is a duplicate file and has been voided.The original event was submitted on medwatch report 3006260740-2022-04071.

• Brand Name: FULL KIT 22G X 8 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15708837
• Report Number: 3006260740-2022-04225
• Device Sequence Number: 12045241
• Product Code: FOZ
• UDI-Device Identifier: 00801741140693
• UDI-Public: (01)00801741140693
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/22/2022

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: F322088PT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 3 YR
• Patient Sex: Unknown