MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381223
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
None reported bd insyte bl 22ga x 1.0in catheter broke separated.It was reported by the customer that the clinic reports 1 opened box of 50, instye iv catheter, 22 g x 1.0¿, part number: 381223, lot 4025720, exp.1/29 ¿ stylet came off of the vein of the patient.They were able to remove with no adverse events to report but do not want to keep remaining product.Verbatim: rcc received a complaint via email.The clinic reports 1 opened box of 50, instye iv catheter, 22 g x 1.0¿, part number: 381223, lot 4025720, exp.1/29 ¿ stylet came off of the vein of the patient.They were able to remove with no adverse events to report but do not want to keep remaining product.Additional info: we are waiting on an update from the customer.As there are now additional questions below, we will follow up for the additional information.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material#: 381223 batch#: 4025720.It was reported by the customer that the clinic reports 1 opened box of 50, instye iv catheter, 22 g x 1.0¿, part number: 381223, lot 4025720, exp.1/29 ¿ stylet came off of the vein of the patient.They were able to remove with no adverse events to report but do not want to keep remaining product verbatim: rcc received a complaint via email.Email(s) attached the clinic reports 1 opened box of 50, instye iv catheter, 22 g x 1.0¿, part number: 381223, lot 4025720, exp.1/29 ¿ stylet came off of the vein of the patient.They were able to remove with no adverse events to report but do not want to keep remaining product additional info: we are waiting on an update from the customer.As there are now additional questions below, we will follow up for the additional information.Additional info: apologies on the delay.We have been following up with the customer for this information that you requested below.As soon as i have an update, i will pass along.Additional info: 1.Can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6) 2024.Total number of occurrences? one 3.Any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? no photo.1.Please confirm with is "stylet" refers to needle or catheter? the catheter 2.Also confirm happened before use or during any infusion? noticed the plastic catheter part stayed in the vein when we were removing the whole catheter from the pet.A tech was able to grab the stylet with a pair of hemastats.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of affected batch.Current control there is a functional test in place to check for catheter to adapter pull force.There is also in-process visual inspection in place to check for catheter damage.No photo/sample was received for further investigation.Root cause could not be determined.The complaint will be re-opened and re-investigated when sample/photo is received.The complaint trend will continue to be tracked and monitored.

• Brand Name: BD INSYTE BL 22GA X 1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20699595
• Report Number: 2243072-2024-01133
• Device Sequence Number: 6583784
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: (01)00382903812233(11)240201(17)290131(10)4025720
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 381223
• Device Lot Number: 4025720
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown