MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK PICC PLUS CRESCENT SLIDING POST; STAND, INFUSION

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
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 juduf651 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that complainant received a call directly from attendant of patient where they mentioned that statlock looses its stickness within 8-10 days.It was stated according to them and based on their previous experience statlock last on skin for six months.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a statlock adhesion issue is inconclusive due to non-original product image sample.Two photo samples of a statlock picc plus securement device were provided for evaluation.The first image shows the product packaging without the device being visible.The product information shows lot: juduf651.The second image appears to show the back portion of the statlock packaging.The components are present within the packaging and appears to be sealed.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.Since the reported issue could not be observed from the images provided, the complaint could not be confirmed and remains inconclusive at this time.The instructions for use (ifu) state, "statlock stabilization device should be replaced at least every 7 days." a lot history review (lhr) of juduf651 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that complainant received a call directly from attendant of patient where they mentioned that statlock looses its stickness within 8-10 days.It was stated according to them and based on their previous experience statlock last on skin for six months.

• Brand Name: STATLOCK PICC PLUS CRESCENT SLIDING POST
• Common Device Name: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10518253
• Report Number: 3006260740-2020-03208
• Device Sequence Number: 2555147
• Product Code: FOX
• UDI-Device Identifier: 00801741082948
• UDI-Public: (01)00801741082948
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: 06/28/2022
• Device Model Number: N/A
• Device Catalogue Number: PIC0220
• Device Lot Number: JUDUF651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1