MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK IV ULTRA; STAND, INFUSION

Catalog Number IVK0100

Device Problems Inadequate Instructions for Healthcare Professional (1319); Loose or Intermittent Connection (1371); Misconnection (1399)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of judz2100 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported via ms&s "nurse caller with bd insyte autoguard bc pro (reference# (b)(4).Lot# 9248850) using in conjunction with bard/bd statlock iv ultrastabilization device (reference#: (b)(4), lot#: judz2100) states nurses in her hospital are losing iv accesses and are frustrated that the two products do not seem to be working together and this is what her hospital has supplied them.Caller also emailed pictures of products with email: "hi, here are photos of the catheter and the statlock device that we have been provided at our hospital.We did not get an in-service on using the statlock device.Many nurses are trying to put the device on as in the first picture which does not secure the catheter at all.The second picture shows what appears to be the proper way to use it although it¿s still not all that secure.The catheter still moves under the device and does not appear to actually lock it in place." ms&s responded "asked caller to email me pictures of products and she emailed six photos (attached here).Emailed response to caller as follows per request:"hi, thank you for reaching out today.I received the six pictures you sent and have attached them all here for reference.As i mentioned, i will be forwarding this case to our filed assurance/quality department for review related to your issues with the bard/bd statlock iv ultra stabilization device with the bd insyte autoguard bc pro.With regard to the bard/bd statlock used with the bd insyte autoguard iv catheters, we understand it typically to be that the bard/bd statlock iv ultra stabilization device https://www.Bardaccess.Com/products/stabilization/piv-ultra is used for non-winged sets and the bard/bd statlock iv select https://www.Bardaccess.Com/products/stabilization/piv-select is used for winged sets.The bard/bd statlock iv select can also be used for nonwinged sets.I have attached documents for your review.In the bd insyte autoguard¿ bc pro (points to practice in-service manual) from the webpage: https://www.Bd.Com/en-us/offerings/capabilities/vascular-access/vascular-iv-catheters/peripheral-iv-catheters/insyte-autoguard-bc-proshielded- iv-catheter-with-blood-control-technology where it states ¿stabilize the catheter and apply a sterile dressing according to your policy.¿ in the attached i.V.Select stabilization device wallchart at: https://www.Bardaccess.Com/products/stabilization/piv-select where it provides a securement visual to include the statement ¿3.Apply adhesive strip or sterile transparent dressing per hospital protocol.¿ there are three bard/bd.Statlock iv select stabilization device application, removal, and in-service videos at: https://www.Bardaccess.Com/products/stabilization/piv.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a statlock device not securing to an iv hub is inconclusive due to the state of the returned sample.Five photographs of an iv ultra statlock device were returned for evaluation.An initial visual observation of three of the photographs showed a 20 g iv in three different positions within the retainer of an iv ultra statlock device.No obvious damage could be seen on the statlock device within the returned photos; however, the quality of the photographs prevented inspection of the sample in greater detail.Possible causes of a poor connection include improper positioning of the statlock retainer on the hub of the iv and/or a damaged retainer or hub.H3 other text: evaluation findings are in section h11.

Event Description

It was reported via ms&s "nurse caller with bd insyte¿ autoguard¿ bc pro (reference# (b)(4), lot# 9248850) using in conjunction with bard/bd statlock® iv ultrastabilization device (reference# (b)(4), lot# judz2100) states nurses in her hospital are losing iv accesses and are frustrated that the two products do not seem to be working together and this is what her hospital has supplied them.Caller also emailed pictures of products with email:"hi, here are photos of the catheter and the statlock device that we have been provided at our hospital.We did not get an in-service on using the statlock device.Many nurses are trying to put the device on as in the first picture which does not secure the catheter at all.The second picture shows what appears to be the proper way to use it although it¿s still not all that secure.The catheter still moves under the device and does not appear to actually lock it in place." ms&s responded "asked caller to email me pictures of products and she emailed six photos (attached here).Emailed response to caller as follows per request:"hi, thank you for reaching out today.I received the six pictures you sent and have attached them all here for reference.As i mentioned, i will be forwarding this case to our filed assurance/quality department for review related to your issues with the bard/bd statlock® iv ultra stabilization device with the bd insyte¿ autoguard¿ bc pro.With regard to the bard/bd statlock® used with the bd insyte¿ autoguard¿ iv catheters, we understand it typically to be that the bard/bd statlock® iv ultra stabilization device https://www.Bardaccess.Com/products/stabilization/piv-ultra is used for non-winged sets and the bard/bd statlock® iv select https://www.Bardaccess.Com/products/stabilization/piv-select is used for winged sets.The bard/bd statlock® iv select can also be used for nonwinged sets.I have attached documents for your review.In the bd insyte¿ autoguard¿ bc pro (points to practice in-service manual) from the webpage: https://www.Bd.Com/en-us/offerings/capabilities/vascular-access/vascular-iv-catheters/peripheral-iv-catheters/insyte-autoguard-bc-proshielded- iv-catheter-with-blood-control-technology where it states ¿stabilize the catheter and apply a sterile dressing according to your policy.¿ in the attached i.V.Select stabilization device wallchart at: https://www.Bardaccess.Com/products/stabilization/piv-select where it provides a securement visual to include the statement ¿3.Apply adhesive strip or sterile transparent dressing per hospital protocol.¿ there are three bard/bd.Statlock® iv select stabilization device application, removal, and in-service videos at: https://www.Bardaccess.Com/products/stabilization/piv.

• Brand Name: STATLOCK IV ULTRA
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10876214
• MDR Text Key: 219198261
• Report Number: 3006260740-2020-20594
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IVK0100
• Device Lot Number: JUDZ2100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other