MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE SL 65 CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Extravasation (1842); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
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 refr1269 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refr1269) have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported crack with overflow.No other information was provided.
Event or Problem Description
Crack with overflow.Add info received: ¿ was there any harm to the patient/health worker? (detail) ans: new access required, the catheter was implanted on (b)(6) 2021 (109 days of use).¿ was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc)? (detail) answer: no.¿ was the catheter fracture internal to the patient or external? ans: all external ruptures in the hub/catheter body connection.¿ any patient symptoms related to fluid leakage? ans: a patient with local hyperemia due to antineoplastic leakage ¿ has the catheter been removed? has a new catheter been placed? ans: a new catheter was placed.¿ what type of catheter fixation was used? ans: tegaderm and iv-fix.¿ has there been blood or chemotherapy exposure to mucous membranes or skin? (detail) ans: there was exposure to an antineoplastic.
Event or Problem Description
It was reported, crack with overflow.Add info received: ¿ was there any harm to the patient/health worker? (detail) ans: new access required, the catheter was implanted on 11/05/2021 (109 days of use) ¿ was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc)? (detail) answer: no.¿ was the catheter fracture internal to the patient or external? ans: external rupture in the hub/catheter body connection ¿ any patient symptoms related to fluid leakage? ans: a patient with local hyperemia due to antineoplastic leakage ¿ has the catheter been removed? has a new catheter been placed? ans: a new catheter was placed.¿ what type of catheter fixation was used? ans: tegaderm and iv-fix.¿ has there been blood or chemotherapy exposure to mucous membranes or skin? (detail) ans: there was exposure to an antineoplastic.
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 catheter leak was inconclusive with the provided information.A photograph was provided which depicted a per-q-cath picc.The catheter was pictured within a clear plastic bag and contained traces of blood-like residue.No observable evidence could confirm the customer event or suggest a potential root cause.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.H3 other text : evaluation findings are in section h.1.

• Brand Name: PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE SL 65 CM
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14317196
• Report Number: 3006260740-2022-01684
• Device Sequence Number: 5000234
• 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
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 4133105
• Device Lot Number: REFR1269
• 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: 05/27/2022; 06/24/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/09/2022; 06/29/2022
• 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: Required Intervention; Other
• Patient Sex: Unknown