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

Model Number	N/A
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of judxf064 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the bonding caused the stabilizer to break.No other information was provided.
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 damaged statlock is confirmed; however, the exact cause of the damage could not be determined from the returned photographs.Two photographs of a picc plus statlock device were returned for evaluation.An initial visual observation of one of the photographs showed a damaged statlock device in a clear plastic bag.The foam pad of the device appears to be torn in two and the retainer appears to be completely detached from the pad.The left side of the pad appears to be detached from and repositioned on the liner, and the right side of the pad appears to be still attached to the liner.What appears to be an impression from the retainer was observed in the foam of the right side of the pad.No detail of the damage could be discerned from the returned photograph.A lot history review (lhr) of judxf064 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the bonding caused the stabilizer to break.No other information was provided.Additional information received stated within complaint comments on 03.Aug.2020: "the healthcare staff was performing the curing to the patient and at the moment of preparing the device and removing the paper that it brings, considering that it was too adhered to its packaging, it causes the device to break.The damage was in the package (not in the statlock).There is adhesive in the package, that makes more difficult the moment of opening it to use the device.The issue was noticed prior device use.There was no patient involvement.".

• Brand Name: STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP
• Common Device Name: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10348015
• Report Number: 3006260740-2020-02717
• Device Sequence Number: 16986768
• Product Code: FOX
• UDI-Device Identifier: 00801741083365
• UDI-Public: (01)00801741083365
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: 09/28/2022
• Device Model Number: N/A
• Device Catalogue Number: VPPCSP
• Device Lot Number: JUDXF064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1