MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SAF-T-INTIMA W/Y ADAPTER PNK 20GAX1.0IN; INTRAVASCULAR CATHETER

Catalog Number 383336

Device Problem Leak/Splash (1354)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/14/2021

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.(b)(4).

Event Description

It was reported that saf-t-intima w/y adapter pnk 20gax1.0in needle went through the tubing and stuck the rn.The following information was provided by the initial reporter: material no.: 383336 batch no.: 0206479.It was reported that when placing pressure on pink area close to the needle.Needle poked through plastic and stuck the rn's thumb.Hi, we had an incident today and need to know direction the bd would like to go? i am thinking we will need to set up an in-service for the department.Today in gi lab one of my rn's sustained a significant exposure with the use of a bd saf-t-intima 20 ga needle.She accessed the vein, was securing the device in the vein by placing pressure on the pink area close to the needle (area we hold to insert the needle) and when she was pulling back on the area we use to pull out the needle the needle actually poked thru the plastic (right below the pink area she was holding to secure the iv in the pt) and she sustained a needle stick to her thumb.I have done all the appropriate associate health & wellness things but wanted to contact you because other staff in gi lab are saying this has happened to them.I do have the packaging from todays incident if you want it.Per customer response: was there medical intervention for the needle stick? the rn in gi lab was starting an iv for a gi procedure.What was the rn¿s outcome? the pt was tested and is negative.Rn will not need to be tested.Needle puncture is healing.You stated that the issue has occurred before, were the incidents reported to bd? the previous occurrences were not reported to bd as manager was not aware they had occurred.If not, can you please fill out the attached complaint form with the additional occurrences? if physical samples are available, please provide address they will be returning from.Na.

Manufacturer Narrative

H6: investigation summary a complaint of needle stick injury was received from the customer.To aid in the investigation of this issue, picture samples were returned for evaluation by our quality engineer team.Through examination of the picture samples the failure modes were not observed or confirmed.A device history record review was completed by our quality engineer team for provided lot number 0206479.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the verbatim, a possible cause for the defect is an incorrect procedure during the use of the device, since the puncture could be related, however a definitive root cause cannot be determined through the provided photos.

Event Description

It was reported that saf-t-intima w/y adapter pnk 20gax1.0in needle went through the tubing and stuck the rn.The following information was provided by the initial reporter: material no.: 383336 batch no.: 0206479 it was reported that when placing pressure on pink area close to the needle.Needle poked through plastic and stuck the rn's thumb.Hi, we had an incident today and need to know direction the bd would like to go? i am thinking we will need to set up an in-service for the department.Today in gi lab one of my rn's sustained a significant exposure with the use of a bd saf-t-intima 20 ga needle.She accessed the vein, was securing the device in the vein by placing pressure on the pink area close to the needle (area we hold to insert the needle) and when she was pulling back on the area we use to pull out the needle the needle actually poked thru the plastic (right below the pink area she was holding to secure the iv in the pt) and she sustained a needle stick to her thumb.I have done all the appropriate associate health & wellness things but wanted to contact you because other staff in gi lab are saying this has happened to them.I do have the packaging from todays incident if you want it.Per customer response: ¿ was there medical intervention for the needle stick? the rn in gi lab was starting an iv for a gi procedure.¿ what was the rn¿s outcome? the pt was tested and is negative.Rn will not need to be tested.Needle puncture is healing.¿ you stated that the issue has occurred before, were the incidents reported to bd? the previous occurrences were not reported to bd as manager was not aware they had occurred.O if not, can you please fill out the attached complaint form with the additional occurrences? ¿ if physical samples are available, please provide address they will be returning from.Na.

• Brand Name: SAF-T-INTIMA W/Y ADAPTER PNK 20GAX1.0IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 11305784
• MDR Text Key: 238680133
• Report Number: 9610847-2021-00060
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833368
• UDI-Public: 00382903833368
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383336
• Device Lot Number: 0206479
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other