MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2017
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 for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of juawf732 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the adhesion site on the statlock was not sticky, thus the device could not be fixed on the patient.
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 that the adhesion site was not sticky was inconclusive since the statlock stabilization device was not returned for investigation.The packaging for the statlock stabilization device was the only item returned for investigation.A visual observation of the returned packaging revealed nothing remarkable.Based on the description of the reported event, possible contributing factors include repositioning of the device and patient skin type; however, since the statlock stabilization device was not returned for investigation, the reported event could not be confirmed and the root cause(s) were not identified.Consequently, this complaint is inconclusive at this time.A lot history review (lhr) of juawf732 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the adhesion site on the statlock was not sticky, thus the device could not be fixed on the patient.

• Brand Name: STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP
• Common Device Name: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7187783
• Report Number: 3006260740-2017-02426
• Device Sequence Number: 1888199
• Product Code: KMK
• UDI-Device Identifier: 00801741083365
• UDI-Public: (01)00801741083365
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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 Model Number: N/A
• Device Catalogue Number: VPPCSP
• Device Lot Number: JUAWF732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1