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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Phlebitis (2004)

Event Date 07/05/2022

Event Type  Injury  

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 Description

It was reported the picc's hub ruptured, causing phlebitis at puncture site.

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 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)
• Type of Device: 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
• MDR Text Key: 301572206
• Report Number: 3006260740-2022-03981
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741074820
• UDI-Public: (01)00801741074820
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K954104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 10/22/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 MO
• Patient Sex: Female