MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC PNK 20GA X 1.16IN; PERIPHERAL IV CATHETERS

Catalog Number 382534

Device Problems Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anaphylactic Shock (1703); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd insyte autog bc pnk 20ga x 1.16in was difficult to thread in a patient presenting in anaphylactic shock.The following information was provided by the initial reporter: verbatim: another incident with yet another lot # today- could have created a sentinel event.A patient in anaphylactic shock brought in by private car was rushed into our resuscitation bay, unresponsive with a very thready pulse.As my staff attempted to gain iv access, 2 separate rn's had trouble puncturing the skin and advancing the catheter- 1 was successful, 1 was not.I cannot overstate how critical it was to establish an iv on this patient for lifesaving interventions.2 additional attempts with the 20 iv were unsuccessful.This is a new lot # 3192266.Additional info from customer: (12-oct-2023): what is the quantity of products found defective? sharpness of the needle.Is there any adverse event or serious injury occurred? delay in treatment.Are you able to send samples to bd for investigation? if no, can a photo be provided? none.Was there difficulty puncturing the skin and advancing once in the vein? yes to both.Did the needle appear dull or as if the needle was adhered to the catheter? needle appeared to be dull.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: BD INSYTE AUTOG BC PNK 20GA X 1.16IN
• Type of Device: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17995691
• MDR Text Key: 326379862
• Report Number: 1710034-2023-01219
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825340
• UDI-Public: (01)30382903825340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 382534
• Device Lot Number: 3192266
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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): Life Threatening