MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK DIALYSIS BUTTERFLY TRICOT, HYDROCOLLID; CATHETER SECUREMENT DEVICE

Catalog Number	DI0120CE
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 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 retainer door doesn¿t lock properly and opens after it is closed cannot be verified from the two photographs that were provided for investigation.Photo #1 of 2 showed a statlock device with the retainer door open.It appears that one side of the paper backing is attached to the adhesive side of the substrate.The statlock is attached to the labeling, which shows part number di0120ce and lot number juzjf056.Photo #2 of 2 showed the locking barbs on the retainer door.No damage was noted.While the exact cause of the reported event cannot be determined due to the sample condition.Potential contributing factors of this complaint include adhesive that prevented proper locking of the retainer.The position/type of device being secured in the retainer may also affect the retention properties of the statlock stabilization device.A lot history review (lhr) of juzjf056 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported that the "clamshell" on the statlock did not lock properly and opened after closing it.No patient injury reported.
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 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 retainer door doesn't lock properly and opens after it was closed was confirmed as manufacturing related.The reported event could be related to an inadvertent application of adhesive in the locking area of this unit during the manufacturing process.One statlock device was returned for investigation.A visual observation of the returned statlock device revealed that the adhesive backing was still attached to the substrate, which indicates that the product had not been used.A functional test revealed that the retainer had some retention force, but could be opened without pushing in on the button to unlock the locking arms.A microscopic examination of the sample revealed adhesive under the edge of the locking arm retainer, which would prevent the barbs on the locking arm from sliding underneath the edge.The complaint sample was forwarded to the manufacturing facility for further review.

• Brand Name: STATLOCK DIALYSIS BUTTERFLY TRICOT, HYDROCOLLID
• Common Device Name: CATHETER SECUREMENT DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6341859
• Report Number: 3006260740-2017-00117
• Device Sequence Number: 13713739
• Product Code: KMK
• UDI-Device Identifier: 00801741081644
• UDI-Public: (01)00801741081644(17)180930(10)JUZJF056
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2017

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 Expiration Date: 09/30/2018
• Device Catalogue Number: DI0120CE
• Device Lot Number: JUZJF056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 03/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1