MAUDE Adverse Event Report: ARROW CVC KIT; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number VASCULAR UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problem Anaphylactic Shock (1703)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

Through a review of records the customer reports a suspected allergic reaction to an arrow catheter.The following is reported: patient required admission to icu in (b)(6) 2017 due to a copd exacerbation and respiratory failure.After sedation and intubation, central line placed for vasopressor support.After the central line was inserted, developed hypotension, generalized urticaria, and increased airway pressures.Treated for anaphylaxis with an epinephrine infusion, antihistamines and corticosteroids with good response.Potential culprit exposures were piperacillin tazobactam, latex, chlorhexidine (from the line) and cisatracurium.Subsequently, tested positive to chlorhexidine skin prick test (11 mm) and chlorhexidine intradermal test at 22 mm.He tested negative to latex and cisatracurium.Histamine control was 5 mm via skin prick test, and saline control was 2 mm.Patient condition reported to be fine.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Because the product code was not known, two potential finished good codes were identified based upon additional information received from the sales representative.Based upon the event date, the associated potential lot numbers for each finished good was identified from the sales history of the customer.The device history records for both potential lots were reviewed.No relevant findings were identified to suggest a manufacturing related issue.The customer report of an allergic reaction was confirmed by the event details of the reported complaint.The patient had an allergic reaction and later was confirmed to have a chlorhexidine allergy.Chlorhexidine is included in the coating of the catheter in this kit.The device history records for two potential finished good codes and associated lot numbers identified from sales history were reviewed.No relevant findings were identified to suggest a manufacturing related issue.The instructions-for-use (ifu) provided states the arrowg+ard blue plus antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine, and/or sulfa drugs.Based on the information provided, unintentional use error (patient condition) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

Through a review of records the customer reports a suspected allergic reaction to an arrow catheter.The following is reported: patient required admission to icu in (b)(6) 2017 due to a copd exacerbation and respiratory failure.After sedation and intubation, central line placed for vasopressor support.After the central line was inserted, developed hypotension, generalized urticaria, and increased airway pressures.Treated for anaphylaxis with an epinephrine infusion, antihistamines and corticosteroids with good response.Potential culprit exposures were piperacillin tazobactam, latex, chlorhexidine (from the line) and cisatracurium.Subsequently, tested positive to chlorhexidine skin prick test (11 mm) and chlorhexidine intradermal test at 22 mm.He tested negative to latex and cisatracurium.Histamine control was 5 mm via skin prick test, and saline control was 2 mm.Patient condition reported to be fine.

• Brand Name: ARROW CVC KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• MDR Report Key: 12579511
• MDR Text Key: 277405284
• Report Number: 9680794-2021-00506
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K993691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEDATION.; SEDATION.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR