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

Catalog Number	IV0225
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of jubqf049 showed two other similar product complaint(s) from this lot number, reported from the same swedish facility.Device not returned at this time.
Event or Problem Description
It was reported that the hub on the tube is broken and loose.No other information was provided.No patient injury reported.This file addresses the second device.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a detached male luer adaptor was confirmed, but the cause was unknown.An extension set from a statlock iv plus kit was returned for investigation.The male luer connector was received separate from the pvc tube.The force required to separate the tubing from the luer adaptor was unknown since the returned samples were already damaged.A line of adhesive from the luer to tube connection was observed around the pvc tube between 6.0mm and 6.5mm from the distal end of the extension set tubing.The adhesive line shows the insertion depth of the pvc tubing within the proximal end of the male luer adaptor.No mechanical damage was noted on the tubing or male luer adaptor.The outside diameter of the tubing was within spec.Adhesive residue from the manufacturing process was visible on the tubing.It appeared that the product was manufactured correctly.It is possible that the stress applied to the tubing and male luer adaptor during use exceeded the bond strength of the connection.A lot history review (lhr) of jubqf049 showed two other similar product complaint(s) from this lot number, reported from the same swedish facility.
Event or Problem Description
It was reported that the hub on the tube is broken and loose.No other information was provided.No patient injury reported.This file addresses the second of two devices.

• Brand Name: STATLOCK IV PLUS TRAPEZOIDAL PAD, CLAMSHELL RETAINER, MACRO BORE 6IN LUER LOCK
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6904907
• Report Number: 3006260740-2017-01748
• Device Sequence Number: 99129
• Product Code: FPA
• UDI-Device Identifier: 00801741081712
• UDI-Public: (01)00801741081712
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K980994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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 Catalogue Number: IV0225
• Device Lot Number: JUBQF049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1