MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 18G X10 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This week we had a product malfunction during insertion.A nurse reports when removing the guidewire and needle, the needle separated from the device and guidewire and remained in the patients arm.The nurse was able to remove the needle separately without incident or harm to the patient.No reported resistance or hardship with insertion.Just product malfunction.
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and is pending evaluation.Results are expected soon.A batch history review (bhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the needle detached from the deployment device was confirmed and is likely related to the manufacturing process.A single photograph of a damaged 18g powerglide pro deployment device was returned for evaluation of this complaint.Consistent with the event description, the device contained evidence of clinical use (e.G., the catheter had been deployed off of the needle and usage residue was present on the device).The needle cannula had completely separated from the deployment device housing.No bends were apparent in the needle cannula to indicate a difficult placement or excess manipulation of the device.The proximal end of the needle had been covered with a red sharps protector cap; therefore, the characteristics of the needle in this location could not be observed.The green needle hub was still inlaid within the deployment device housing and appeared unremarkable to gross visual observation.It appears that the proximal end of the needle may have become detached from the needle hub allowing the needle to separate from within the housing.Possible contributing factors could include a weak adhesive bond, an improper cure of the adhesive, or dimensional incompatibility between the needle cannula and needle hub.This event was likely related to the device manufacturing.Bd is working closely with manufacturing to help prevent recurrence of the reported event.A batch history review (bhr) of regx0903 showed no other similar product complaint(s) from this batch number.
Event or Problem Description
It was reported by the customer that "this week we had another product malfunction during insertion.A different nurse reports when removing the guidewire and needle, the needle separated from the device and guidewire and remained in the patients arm.The nurse was able to remove the needle separately without incident or harm to the patient.No reported resistance or hardship with insertion.".

• Brand Name: BASIC KIT 18G X10 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16251116
• Report Number: 3006260740-2023-00153
• Device Sequence Number: 12045470
• Product Code: FOZ
• UDI-Device Identifier: 00801741140518
• UDI-Public: (01)00801741140518
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/28/2023
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F318107T
• Device Lot Number: REGX0903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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 Sex: Unknown