MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX 19G X 0.75 IN W/Y; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Material Separation (1562); Difficult or Delayed Activation (2577); Activation Problem (4042)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of afdps0086 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that "the security system of the needle is separated from the device and it was impossible to active it.It happened at the initial use of the product.Danger of needlestick injury.".

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a safety mechanism separating from the device was inconclusive because no sample was returned for evaluation.Based on the description of the reported event, possible contributing factors include damage during storage or handling and damage due to excessive closing force; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time.A lot history review (lhr) of asdps0086 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that "the security system of the needle is separated from the device and it was impossible to active it.It happened at the initial use of the product.Danger of needlestick injury.".

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint of a detached safety base is inconclusive since the original sample was not returned.Nine powerloc max 19 ga x 0.75 in infusion sets were returned in sealed packaging.The product information showed lot: asdps0086.Three of the outer packages are marked with the text ¿tac¿ in black marker.The samples were opened.The safety mechanism was advanced and fully activated.Additional force was applied to ensure the safety based did not detach.No functional issues were observed with the deployment of the safety mechanism.The product that experienced the reported issue was not returned as the returned samples were within sealed packaging.Since no issues were observed on the returned samples, the complaint is inconclusive.A lot history review (lhr) of asdps0086 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that "the security system of the needle is separated from the device and it was impossible to active it.It happened at the initial use of the product.Danger of needlestick injury.".

• Brand Name: POWERLOC MAX 19G X 0.75 IN W/Y
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8785579
• MDR Text Key: 150994333
• Report Number: 3006260740-2019-01938
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066177
• UDI-Public: (01)00801741066177
• Combination Product (y/n): N
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 84446013
• Device Lot Number: ASDPS0086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Event Location: Hospital
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1