MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 8 CM WITH GUARDIVA AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported by the customer that powerglide extension tubing kinked.No other information was provided.
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 extension set was confirmed; however, the root cause was not identified.The product returned for evaluation was one powerglide pro midline catheter extension set.The sample appeared free of use residues.Two compressed regions were observed in the extension tubing near the proximal luer.The two regions were approximately 2cm apart.The compressed regions did not appear consistent with tubing compression caused by closing the clamp.Microscopic inspection of the compressed regions revealed material buckling and discoloration.The tubing compression did not appear to be caused by utilizing the clamp.The lack of use residues further suggested that the compression did not occur during device use.It could not be determined what caused the catheter compression nor when in the product lifecycle that compression occurred.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include damage during device transportation and storage.A lot history review (lhr) of regp1243 showed no other similar product complaint(s) from this lot number.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by the customer that powerglide extension tubing kinked.Additional information received: it was reported a powerglide midline kit was opened for a midline insertion.When the iv tubing with the purple clamp was flushed with saline in the preparation for the midline insertion, it was noted to have two moderately crimped areas.The midline was placed successfully, but the tubing was not used on the patient.The product never came in contact or was attached to the patient.The midline was being inserted to deliver iv antibiotics at home for tensynovitis.".

• Brand Name: FULL KIT 20G 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: 15540384
• Report Number: 3006260740-2022-03869
• Device Sequence Number: 5997015
• Product Code: FOZ
• UDI-Device Identifier: 00801741140624
• UDI-Public: (01)00801741140624
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/12/2022

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 Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: F220088PT
• Device Lot Number: REGP1243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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