MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Model Number 381423

Device Problems Break (1069); Leak/Splash (1354)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

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 a insyte autoguard bl 22ga x 1.0in was damaged and contributed to a dirty needle stick during use.The following was reported by the initial reporter: "it was reported that the hub is broken.Verbatim: per customer's response (b)(6) 2021.Patient info: (b)(6).Did you receive the photos of the broken item? do you still want it to be sent back to you? per customer's response on 02/22/2021 the document attached states ¿another bd product issue¿, did you have any issues before and have you reported that? this would be a question to.Here in the infusion clinic, we did have an insyte that the needle did not retract after use and the nurse stuck herself on it.Was anyone hurt? in this situation with the broken hub, it caused the patient to have a second iv stick because this one could not be salvaged.The iv site was patent and the patient would not have needed a second site if the item had not failed.Do you have patient identifiers? are you looking for a patient name? can i ask why that information is needed? you stated that you have samples, please find attached return prepaid label of fedex to return samples.Yes, i still have the broken hub in my possession.Here is the issue: iv catheter had a small section of the hub that was broken and unable to connect to tubing without leaking blood.This was impossible to see before use.This resulted in having to poke the patient a second time due to the faulty item.Lot number: 0139118.The product was kept so please let us know if we should send this back.I have included the manager who has the product currently on this email.Thanks! the product was kept so please let us know if we should send this back.I have included the manager who has the product currently on this email.Credit requested i am hoping you can forward along a another product issue we had with item# 18870, bd# 381423.This one was at munson medical center for becton dickenson on the below product: hello.Here is a photo of the broken hub.Hub on bd insyte autoguard shielded iv catheter broke.Item# 18870.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 3/1/2021.H6: investigation: bd received a 22 gauge insyte autoguard blood control unit from lot 0139118 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed damage to the inside of the luer.Next, a leakage test was performed on the returned unit and leakage was observed coming from the luer.Based off the visual inspection and testing the engineer was able to verify the reported defect.It was determined that this was a manufacturing defect that occurred during the assembly process.A misalignment between the adapter and the manufacturing equipment can cause the observed damage.

Event Description

It was reported that a insyte autoguard bl 22ga x 1.0in was damaged and contributed to a dirty needle stick during use.The following was reported by the initial reporter: "it was reported that the hub is broken verbatim: per customer's response 02/22/2021.Patient info: 66 y.O female, dob: (b)(6) 1954.Did you receive the photos of the broken item? do you still want it to be sent back to you? per customer's response on 02/22/2021.The document attached states ¿another bd product issue¿, did you have any issues before and have you reported that? this would be a question to.Here in the infusion clinic, we did have an insyte that the needle did not retract after use and the nurse stuck herself on it.Was anyone hurt? in this situation with the broken hub, it caused the patient to have a second iv stick because this one could not be salvaged.The iv site was patent and the patient would not have needed a second site if the item had not failed.Do you have patient identifiers? are you looking for a patient name? can i ask why that information is needed? you stated that you have samples, please find attached return prepaid label of fedex to return samples.Yes, i still have the broken hub in my possession.Here is the issue: iv catheter had a small section of the hub that was broken and unable to connect to tubing without leaking blood.This was impossible to see before use.This resulted in having to poke the patient a second time due to the faulty item.Lot number: 0139118.The product was kept so please let us know if we should send this back.I have included the manager who has the product currently on this email.Thanks! the product was kept so please let us know if we should send this back.I have included the manager who has the product currently on this email.Credit requested i am hoping you can forward along a another product issue we had with item# 18870, bd# 381423.This one was at munson medical center for becton dickenson on the below product: hello.Here is a photo of the broken hub.Hub on bd insyte autoguard shielded iv catheter broke.Item# 18870.".

• Brand Name: INSYTE AUTOGUARD BL 22GA X 1.0IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11490438
• MDR Text Key: 240309877
• Report Number: 1710034-2021-00188
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814238
• UDI-Public: 30382903814238
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 381423
• Device Catalogue Number: 381423
• Device Lot Number: 0139118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR