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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refr1295 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "when doing powerglide training, during a bedside insertion, catheter was placed without difficultly (no resheathing of catheter or stress to device noted).After catheter was advanced attempted to aspirate blood return and air was noted entering the syringe.Insured that extension set was secure and properly attached.Again attempted to aspirate for blood return and air again noted entering the syringe, when flushing catheter was noted to be leaking where the catheter joins the hub.Catheter dc'ed intact with no injury to patient." add info rcvd 09/17/2021: what they¿re being treated for: rhabdomyolysis.
Event or Problem Description
It was reported "when doing powerglide training, during a bedside insertion, catheter was placed without difficultly (no resheathing of catheter or stress to device noted).After catheter was advanced attempted to aspirate blood return and air was noted entering the syringe.Insured that extension set was secure and properly attached.Again attempted to aspirate for blood return and air again noted entering the syringe, when flushing catheter was noted to be leaking where the catheter joins the hub.Catheter dc'ed intact with no injury to patient." add info rcvd 09/17/2021: what they¿re being treated for: rhabdomyolysis.
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 leaking catheter was confirmed.The product returned for evaluation was one 20ga x 10cm powerglide pro catheter.Light usage residues were observed and the catheter exhibited curved shape memory.A v-shaped split was observed just distal of the molded joint between the luer adapter and catheter shaft.Microscopic inspection of the split revealed glossy, sharply defined fracture features.A regular, striated pattern was observed throughout the fracture surface.The fracture exhibited a tapered profile.The damage was consistent with contact between the catheter shaft and a sharp, pointed instrument such as a needle.Such damage can occur if the catheter is with drawn onto the introducer needle and/or if the needle is re-inserted following catheter advancement.This appeared consistent with the event description, which indicated that leakage was noted immediately following device placement.H3 other text : evaluation findings are in section h.11.

• Brand Name: FULL 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12565291
• Report Number: 3006260740-2021-04110
• Device Sequence Number: 11132648
• Product Code: FOZ
• UDI-Device Identifier: 00801741140730
• UDI-Public: (01)00801741140730
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/16/2021

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 Model Number: N/A
• Device Catalogue Number: F320108T
• Device Lot Number: REFR1295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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: Other
• Patient Age: 18 YR
• Patient Sex: Unknown
• Patient Weight: 82 KG