MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 2F BASIC TRAY (SINGLE-LUMEN) (30 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 Code	Vasculitis (2004)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redx4173 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the picc's hub ruptured, causing phlebitis at puncture site.
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.
Event or Problem Description
It was reported the picc's hub ruptured, causing phlebitis at puncture site.10/04/2022: add info received: was there a need for medical and/or surgical intervention to treat phlebitis (examinations, surgery, medication administration, etc.)? (detail) not.Has there been blood or chemotherapy exposure to mucous membranes or skin? if yes, were post-exposure prophylactic actions necessary? (ex.: tests, retrovirals, etc.); yes, patient skin without the need for prophylaxis.Is the amount correct (01)? yes.How and when did you observe the rupture? (eg during infusion, during implantation, removal, etc.); it was observed due to humidity in the place.What medication was being administered? saline solution was being administered to maintain access.What is the volume of the syringe used for infusion? 10 ml.What type of catheter fixator was being used? occluded with transparent film, fixed according to institutional protocol.What is the implant date? on (b)(6) 2022.Has the device been removed? if yes, what is the explant date? yes, on (b)(6) 2022.What was the puncture site (arm, vessel, etc.)? picc inserted into the saphenous vein.What is the patient's sex, weight and age? female, 2870 grams and 2 months.What treatment was the patient undergoing? acute viral bronchiolitis and pneumonia.Is there any relevant history or concomitant therapy? no.Are there radiographic images or other tests done? no.Was there an embolism or component separation? if yes, how was it resolved? no.

• Brand Name: PER-Q-CATH PLUS PICC 2F BASIC TRAY (SINGLE-LUMEN) (30 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15587614
• Report Number: 3006260740-2022-03981
• Device Sequence Number: 12557563
• Product Code: LJS
• UDI-Device Identifier: 00801741074820
• UDI-Public: (01)00801741074820
• 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: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2022

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: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 4132005
• Device Lot Number: REDX4173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 10/22/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• 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 Age: 2 MO
• Patient Sex: Female