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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2022
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 refy1503 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "placed on first stick.Easy access.Dc' d without resistance." it was reported "went in like butter that when it was pulled only 2cm came out.Dr trying to send this guy to oly for a "cut down".Appears catheter is still in basilic." additional information received on (b)(6) 2022: a detailed description of the event: powerglide pro rt 20gax10cm was placed with ultrasound guidance, lot # refy1503, ref # f120108pt, exp date, 01-31-2023.It was placed in one attempt with successful blood return, and was tolerated without discomfort.Upon removal, there was no resistance.1.5 cm of the catheter attached to the hub was present.Interventions and precautions were taken and imaging demonstrated approximately 6 cm of retained catheter.The patient was scheduled for removal of the catheter at another facility.How was the break and/or retained segment discovered? it was discovered upon attempted removal of the device.Were all the missing/broken pieces retrieved and accounted for? see above.Did the patient require surgery to remove the broken piece? the patient was scheduled for a procedure at another facility to have the broken tubing removed.What type of catheter securement was utilized? the device was secured with the statlock device included in the full kit.At what point during device use (i.E.Insertion, infusion, removal) did the break occur? the break was discovered upon removal of the device at the end of the study, it has not been determined when the break occurred.Any long-term patient harm? unknown.
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 powerglide catheter was confirmed.The product returned for evaluation was one 20ga x 10cm powerglide pro midline catheter.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as a scalpel.The returned product sample was evaluated and a break was observed approximately 1cm from the molded joint.Microscopic examination of the catheter break confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: ¿ the fracture surface was partially reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.¿ sharply formed fracture edges.¿ planar shape to the fracture surface.The short time frame between the insertion date and the date of discovery suggests this damage likely occurred during insertion.The partially striated and partially granular fracture surface suggested that damage was initiated through sharp instrument contact and subsequently propagated due to pulling stress.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.
Event or Problem Description
It was reported "placed on first stick.Easy access.Dc' d without resistance." it was reported "went in like butter that when it was pulled only 2cm came out.Dr (b)(6) to send this guy to oly for a "cut down".Appears catheter is still in basilic." additional information received: ¿ a detailed description of the event: powerglide pro rt 20gax10cm was placed with ultrasound guidance, lot # refy1503, ref # f120108pt, exp date, 01-31-2023.It was placed in one attempt with successful blood return, and was tolerated without discomfort.Upon removal, there was no resistance.1.5 cm of the catheter attached to the hub was present.Interventions and precautions were taken and imaging demonstrated approximately 6 cm of retained catheter.The patient was scheduled for removal of the catheter at another facility.¿ how was the break and/or retained segment discovered? it was discovered upon attempted removal of the device.¿ were all the missing/broken pieces retrieved and accounted for? see above.¿ did the patient require surgery to remove the broken piece? the patient was scheduled for a procedure at another facility to have the broken tubing removed.¿ what type of catheter securement was utilized? the device was secured with the statlock device included in the full kit.¿ at what point during device use (i.E.Insertion, infusion, removal) did the break occur? the break was discovered upon removal of the device at the end of the study, it has not been determined when the break occurred.¿ any long-term patient harm? unknown.

• Brand Name: FULL KIT 20G X 10 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14117963
• Report Number: 3006260740-2022-01317
• Device Sequence Number: 14026062
• Product Code: FOZ
• UDI-Device Identifier: 00801741140587
• UDI-Public: (01)00801741140587
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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: F120108PT
• Device Lot Number: REFY1503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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: Male
• Patient Weight: 77 KG