MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 4F SINGLE-LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Defective Component (2292); Material Deformation (2976)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Perforation (2001); Swelling/ Edema (4577)
Date of Event	06/22/2022
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 reez3337 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a technical complaint regarding the material central catheter insercao perif.Picc 4fr x 65cm because during the procedure of passing the catheter after puncture, the material broke causing damage to the patient's blood vessel and also causing edema at the site with risk of extensive hematoma.It was immediately withdrawn.On 06/27/2022: add info received: was there any harm, other than what was mentioned, to the patient? yes, patient had bruises.What was done to continue treatment? another type of catheter was passed into the patient.Has there been blood or chemotherapy exposure to mucous membranes or skin? yes.What medication was being administered? none.Was there a need for medical intervention due to the event (imaging exams, medication administration, etc)? no.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged introducer sheath is confirmed; however, the exact cause is unknown.Two photographs of an excalibur microintroducer sheath were returned for evaluation.An initial visual observation of the photographs showed the distal tip of the sheath was damaged.One edge of the distal tip of the sheath was observed to be plastically deformed and the material was observed to protrude outward.Blood residue was observed on the sample in the returned photographs.No further details could be seen of the damage on the distal tip of the sheath in the returned photographs.While the cause of the damage observed on the introducer sheath tip could not be determined from the returned photographs, possible contributing factors include insertion angle, advancement against resistance, and damage during handling or use.
Event or Problem Description
It was reported that a technical complaint regarding the material central catheter insercao perif.Picc 4fr x 65cm because during the procedure of passing the catheter after puncture, the material broke causing damage to the patient's blood vessel and also causing edema at the site with risk of extensive hematoma.It was immediately withdrawn.06/27/2022: add info received: was there any harm, other than what was mentioned, to the patient? yes, patient had bruises.What was done to continue treatment? another type of catheter was passed into the patient.Has there been blood or chemotherapy exposure to mucous membranes or skin? yes what medication was being administered? none.Was there a need for medical intervention due to the event (imaging exams, medication administration, etc)? no.

• Brand Name: PER-Q-CATH PLUS PICC 4F SINGLE-LUMEN PICC
• 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: 15005554
• Report Number: 3006260740-2022-02692
• Device Sequence Number: 2316951
• Product Code: LJS
• UDI-Device Identifier: 00801741074875
• UDI-Public: (01)00801741074875
• 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,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 4134105
• Device Lot Number: REEZ3337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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 Sex: Unknown