MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 22G X 8 CM WITH GUARDIVA 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	05/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refz1191 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "perfectly in the center of the vessel.Advanced wire without resistance and advanced catheter threaded without resistance at the very end slight resistance.Went to safety the needle and resistance.Couldn¿t pull back.Hub of catheter broke from catheter.Had to use forceps to get needle and guide wire out.Catheter stuck in patient forearm.".
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 a damaged midline catheter was confirmed.The product returned for evaluation was one 22ga x 8cm powerglide pro midline catheter assembly.The catheter had been advanced and the safety mechanism was engaged over the needle tip.The catheter shaft exhibited a complete break dust distal of the molded joint.The distal catheter fragment was not returned for evaluation.The break site appeared irregular.Microscopic inspection of the break site revealed a partially glossy and partially dully granular fracture surface.The break exhibited a tapered profile.The break features were consistent with the catheter being damaged by contact with the introducer needle tip.Such damage can occur if the catheter is pulled back onto the needle and if the needle is re-inserted following catheter advancement.
Event or Problem Description
It was reported "perfectly in the center of the vessel.Advanced wire without resistance and advanced catheter threaded without resistance at the very end slight resistance.Went to safety the needle and resistance.Couldn¿t pull back.Hub of catheter broke from catheter.Had to use forceps to get needle and guide wire out.Catheter stuck in patient forearm.".

• Brand Name: FULL KIT 22G X 8 CM WITH GUARDIVA 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: 14518128
• Report Number: 3006260740-2022-01967
• Device Sequence Number: 15112106
• Product Code: FOZ
• UDI-Device Identifier: 00801741140594
• UDI-Public: (01)00801741140594
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: F122088PT
• Device Lot Number: REFZ1191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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: Required Intervention
• Patient Sex: Unknown