MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV PLUS STABILIZATION DEVICE, 6" MACRO EXT, SETS, NEEDLE ACCESS PORT; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	IV0225
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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) review is not possible, as no manufacturing lot number has been provided by the complainant.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that the extension tubing has snapped - cause unknown.
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 is unknown.One extension set was returned for investigation.The male luer adaptor had separated from the pvc tubing.The force required to separate the tubing from the luer adaptor is unknown since the returned sample was already damaged.Evidence of use was noted on the complaint sample, which indicates that the product was damaged while in use.Residue was observed throughout the pvc tubing and connectors.The pvc tubing was discolored near the female luer connector.No mechanical damage was noted on the tubing or male luer adaptor.The outside diameter of the tubing and the inside diameter of the connector were within spec.Adhesive residue was visible on the tubing and within the male luer adaptor.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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the extension tubing has snapped - cause unknown.

• Brand Name: STATLOCK IV PLUS STABILIZATION DEVICE, 6" MACRO EXT, SETS, NEEDLE ACCESS PORT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6525699
• Report Number: 3006260740-2017-00516
• Device Sequence Number: 316641
• 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
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1