MAUDE Adverse Event Report: STATLOCK IV PLUS TRAPEZOIDAL PAD, CLAMSHELL RETAINER, MACRO BORE 6IN LUER LOCK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of juex0923 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the ¿powerglide midline extension set became disconnected, when pulled or caught, leaving the catheter open to air.The disconnection occurred where the inflexible proximal end (near the luer lock) is joined to the flexible, longer, distal part, that houses the external clamp.
Additional 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 detached luer connector is confirmed but the exact cause remains unknown.Two photo samples of a statlock iv plus extension set were provided for evaluation.The first image shows the kit packaging and extension set.The packaging information indicates lot: juez0923.The extension set is shown with the clamp present over the tubing.The male luer connector is completely detached from the extension tubing.The second image shows a closer view of the extension set.No evidence of a tubing fracture was noted.Adhesive rings appear to be present on the extension tubing.Based on the information provided, possible contributing factors include exposure to excessive tensile forces and material fatigue.Since the extension tubing was observed to be detached from the connector, the complaint is confirmed but the exact cause remains unknown.
Event or Problem Description
It was reported that the ¿powerglide midline extension set became disconnected, when pulled or caught, leaving the catheter open to air.The disconnection occurred where the inflexible proximal end (near the luer lock) is joined to the flexible, longer, distal part, that houses the external clamp.

• Brand Name: STATLOCK IV PLUS TRAPEZOIDAL PAD, CLAMSHELL RETAINER, MACRO BORE 6IN LUER LOCK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12343078
• Report Number: 3006260740-2021-03400
• Device Sequence Number: 4381415
• Product Code: FPA
• UDI-Device Identifier: 00801741081712
• UDI-Public: (01)00801741081712
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K980994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IV0225
• Device Lot Number: JUEX0923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other