MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 20G X 10 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "during insertion, attempted to advance catheter over the needle.Went to pull back on needle and felt resistance.Rn and pa unable to manually remove.Pa administered sq lidocaine to relax the vessel and was able to remove it.It appears intact but it looks as if there is a break or bent inside the catheter.The catheter is definitely sheered in the middle.".
Additional Manufacturer Narrative
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regs0747 showed no other similar product complaint(s) from this lot number.
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; however, the root cause was not identified.The products returned for evaluation were two photographs which depicted a 20ga x 10cm powerglide pro midline catheter assembly.The depicted portion included the catheter and a portion of the needle shaft.Usage residues were evident throughout the visible portion of the device.The catheter was partially advanced.A complete break was observed approximately midway along the length of the catheter shaft.The distal segment of the catheter was severely bunched on the guidewire near the tip of the needle.Damage was evident in the submitted photographs; however, inspection of the photographs was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include attempted insertion against resistance and retraction of the catheter against the needle tip following advancement.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "during insertion, attempted to advance catheter over the needle.Went to pull back on needle and felt resistance.Rn and pa unable to manually remove.Pa administered sq lidocaine to relax the vessel and was able to remove it.It appears intact but it looks as if there is a break or bent inside the catheter.The catheter is definitely sheered in the middle.".

• Brand Name: BASIC KIT 20G X 10 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: 15299367
• Report Number: 3006260740-2022-03321
• Device Sequence Number: 15259514
• Product Code: FOZ
• UDI-Device Identifier: 00801741140532
• UDI-Public: (01)00801741140532
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/16/2022

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 Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: F320107T
• Device Lot Number: REGS0747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 42 KG