MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the catheter was inserted in a patient and had a microhole when it returned for maintenance.
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refq3534 showed three other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the catheter was inserted in a patient and had a microhole when it returned for maintenance.Add info received: was there any harm to the patient/health worker? (detail) no.Was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc)? (detail) no.Was the catheter fracture internal to the patient or external? external rupture in the hub/catheter body connection.Any patient symptoms related to fluid leakage? a patient with local hyperemia due to antineoplastic leakage.Has the catheter been removed? has a new catheter been placed? ruptured catheter was returned and reported to the quality department, patient was subjected to a new catheter.What type of catheter fixation was used? tegaderm and iv-fix.What medication was being administered? not informed.
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: previous complaints, patient severity, applicable manufacturing records, submitted photograph, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a hole in the catheter was inconclusive with the provided information.A photograph was provided for evaluation which depicted two per-q-cath catheters, each inside a clear plastic bag.Needleless injection caps were attached to the luer hubs of those catheters but no other relevant detail could be determined from evaluation of the image.A review of the manufacture records associated with the provided lot number found no potential cause identified during product manufacture.Should the physical sample be returned at a later time, this investigation will be updated.This event will be recorded for future trending and monitoring of this complaint type.

• Brand Name: PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SINGLE-LUMEN)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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: 14317107
• Report Number: 3006260740-2022-01681
• Device Sequence Number: 20032435
• Product Code: LJS
• UDI-Device Identifier: 00801741074844
• UDI-Public: (01)00801741074844
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 4133105
• Device Lot Number: REFQ3534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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 Sex: Unknown