MAUDE Adverse Event Report: POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 8672034

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asesf900 showed five similar product complaint(s) from this lot number.

Event Description

It was reported that cap on y connection dislodged about an hour after infusion started, causing medication to be lost.Medication was being infused via main port.Per healthcare professional " the cap wasn't checked no - but this will definitely be something we do from now on.We did not feel the cap was faulty, but as we didn't check, we are unsure." no other information was provided.

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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a dislodged y-connector cap was inconclusive since the original sample from the complaint was not returned and could not be tested; however, four sealed powerloc safety infusion sets from the same lot # were returned for evaluation.Upon removal from the package, there appeared to be no visual signs of damage.All of the luer adaptor caps on the y-site were securely connected.A taper gage was used to measure the taper on each of the y-site luer adaptors and each was found to be within specification.In a functional test, a 12 cc syringe was connected to the extension tubing and used to flush each infusion set.All four of the infusion sets were patent to infusion.The clamp between the y-site and the needle was then activated and infusion was attempted again.Each of the infusion sets showed no signs of leakage against pressure and all of the caps on the y-site remained in place.Because the original sample was not returned and because the reported event could not be replicated on the returned samples, the complaint was inconclusive.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that cap on y connection dislodged about an hour after infusion started, causing medication to be lost.Medication was being infused via main port.Per healthcare professional " the cap wasn't checked no - but this will definitely be something we do from now on.We did not feel the cap was faulty, but as we didn't check, we are unsure." no other information was provided.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12167734
• MDR Text Key: 261524503
• Report Number: 3006260740-2021-02748
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741048425
• UDI-Public: (01)00801741048425
• Combination Product (y/n): N
• PMA/PMN Number: K060812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

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
• Device Operator: Health Professional
• Device Model Number: 8672034
• Device Catalogue Number: 8672034
• Device Lot Number: ASESF900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 08/09/2021
• Supplement Dates FDA Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• 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): Other