MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW FLEXBLOCK KIT:ECHO CATH, 17GX9CM NS NDL; ANESTHESIA CONDUCTION KIT

Catalog Number	FB-19609-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "two patients who had procedures using the same kit, developed a deep infection.Both patients needed to be hospitalized and had to have an incision and drainage of an abscess which formed along the catheter tract.The nerve block kit used on both patients had the same lot number".Additional information received states that ""[patient]" developed severe r.Arm pain and immobility, a r.Neck deep abscess with multiple loculations, requiring i & d twice.The first i & d was at beside on (b)(6) 2026, drain left in place.The second i & d was in the or (b)(6) 2026 for further washout - two drains left (1 red rubber, 1 penrose) in the depth of the abscess pocket that were used for irrigation and drainage.The patient was hospitalized from (b)(6) 2026 until (b)(6) 2026 and was discharged home with home health on (b)(6) 2026 with the two drains for irrigation and drainage.The penrose and red rubber were removed on (b)(6) 2026 and the wound was packed by the home health rn.The right is immobile; patient is not able to lift it but is moving his fingers.Surgery was on (b)(6) 2026.Catheter was removed on (b)(6) 2026, symptoms started on (b)(6) 2026 (new pain, numbness, and weakness and unable to do bicep curls.Ed visit on (b)(6) 2026 and readmitted on (b)(6) 2026.Cultures (+) mssa".See associated mdr 9680794-2026-00352.
Event or Problem Description
It was reported that "two patients who had procedures using the same kit, developed a deep infection.Both patients needed to be hospitalized and had to have an incision and drainage of an abscess which formed along the catheter tract.The nerve block kit used on both patients had the same lot number".Additional information received states that ""[patient]" developed severe r.Arm pain and imm obility, a r.Neck deep abscess with multiple loculations, requiring i & d twice.The first i & d was at beside on (b)(6) 2026, drain left in place.The second i & d was in the or (b)(6) 2026 for further washout - two drains left (1 red rubber, 1 penrose) in the depth of the abscess pocket that were used for irrigation and drainage.The patient was hospitalized from (b)(6) 2026 and was discharged home with home health on (b)(6) 2026 with the two drains for irrigation and drainage.The penrose and red rubber were removed on (b)(6) 2026 and the wound was packed by the home health rn.The right is immobile; patient is not able to lift it but is moving his fingers.Surgery was on (b)(6) 2026.Catheter was removed on (b)(6) 2026, symptoms started on (b)(6) 2026 (new pain, numbness, and weakness and unable to do bicep curls.Ed visit on (b)(6) 2026 and readmitted on (b)(6) 2026.Cultures (+) mssa".See associated mdr 9680794-2026-00352.
Additional Manufacturer Narrative
(b)(4).The customer reported the patient had an "infection" after a procedure.The customer returned one representative kit from the same lot # as reported on the complaint (33f25l0351) for investigation.The actual complaint sample was not received.The ifu for this kit was reviewed as a part of this complaint investigation.The ifu warns the end user, "practitioners must be aware of complications associated with continuous peripheral nerve block catheters including but not limited to: infection, intravascular injection, nerve injury, seizure, pneumothorax, bleeding, hematoma and local anesthetic allergy." the ifu also precautions "when distal portion of catheter is pulled through tunnel tract, there may be an increased risk of infection." a corrective action is not required at this time as the complaint could not be confirmed based upon the information provided and without the actual complaint sample.The reported complaint of the patient having an "infection" after a procedure could not be confirmed based on the sample received.The actual complaint sample was not returned; only a representative sample was received.The ifu for this product warns the user complications associated with continuous peripheral nerve block catheters including but not limited to infection, intravascular injection, nerve injury, seizure, pneumothorax, bleeding, hematoma and local anesthetic allergy.Also, the ifu precautions when the catheter is pulled through the tunnel tract, there may be increased risk of infection.A device history record review was performed on the flexblock needle and nerve block catheter with no relevant findings.Based on this, the complaint could not be confirmed based upon the information provided and without the actual complaint sample.No further action is required at this time.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: ARROW FLEXBLOCK KIT:ECHO CATH, 17GX9CM NS NDL
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: azhwan barazenda ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 25086633
• Report Number: 9680794-2026-00353
• Device Sequence Number: 10574231
• Product Code: CAZ
• UDI-Device Identifier: 50801902078525
• UDI-Public: (01)50801902078525(11)251216(17)271130(10)33F25L0351(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: FB-19609-K
• Device Lot Number: 33F25L0351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown