MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 8 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refs4744 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "nurse retracted guidewire and went to sheath the needle noticed that the end was missing (initially thought the guidewire snapped) rushed the patient to er for x-ray - x-ray revealed nothing." additional information received 12/20/2021: "no foreign body was identified on x-ray.The length of guidewire appears to be coiled in the handle of the insertion device.".
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of the guidewire being coiled within the assembly housing was confirmed.The product returned for evaluation was two powerglide pro midline catheter assemblies.Usage residues were observed throughout both samples.Both catheters had been advanced and the catheters were not returned.Both safeties were engaged over the needle tips.Both guidewire advancers were fully advanced; however, no guidewire was visible extending from the needle of the first sample (sample 1).The guidewire was coiled within the housing.Following disassembly of sample 1, inspection of the advancer revealed wear marks in the coupler region.Inspection of the guidewire revealed it to be intact; however, a kink was observed in the wire within the region that had been coiled within the housing.Gross and microscopic inspection of the second sample was unremarkable.The wear marks in the coupler region of the guidewire advancer suggested that the guidewire was initially assembled with the connector.The wire likely subsequently became disengaged by attempted advancement against resistance, such as into tissue.The use residues suggested that resistance occurred during attempted device placement.The second sample appeared to have functioned as intended and may have been returned as a reference.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "nurse retracted guidewire and went to sheath the needle noticed that the end was missing (initially thought the guidewire snapped) rushed the patient to er for x-ray - x-ray revealed nothing." additional information received 12/20/2021: "no foreign body was identified on x-ray.The length of guidewire appears to be coiled in the handle of the insertion device.".

• Brand Name: FULL KIT 18G X 8 CM WITH BIOPATCH
• 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: 13078847
• Report Number: 3006260740-2021-05421
• Device Sequence Number: 4153162
• Product Code: FOZ
• UDI-Device Identifier: 00801741140709
• UDI-Public: (01)00801741140709
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F318088T
• Device Lot Number: REFS4744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 143 KG