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

Model Number N/A

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

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 statlock base separating from the adhesive pad is confirmed; however, the root cause could not be determined.One photograph of a two statlock devices was returned for evaluation.An initial visual observation of the photograph showed a damaged statlock device beside an undamaged statlock device.The damaged statlock device shows that the retainer cell and base is separated from the securement pad.While a separation of the base from the pad was clearly visible in the submitted photographs, inspection of those photographs was insufficient to identify the cause of the separation.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include chemical weakening of adhesive and patient movement.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of juer0726 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (juer0726) have been reported from the same facility.

Event Description

"0147 pt's mother called rn stated pt's picc dressing was no longer intact.Rn went to bedside to assess picc site, found bottom of dressing to be lifted.Mother held pt's arm to prevent movement of picc line.Rn notified mother would be back shortly to perform dressing change." "0155-0225 rn went back to bedside with rn, rn, and rn to perform picc dressing change.Upon closer examination, found picc plus statlock had malfunctioned (plastic wings while still attached to picc had lifted up off of statlock pad).Dressing and statlock device removed, noted that approximately 1cm of catheter was exposed.Rn asked mother if more of the catheter appeared to be exposed since last dressing change.Mom stated that it looked about the same, possibly a little longer.Picc dressing change performed including new statlock device (picc plus pediatric).Rn notified pt's mother that medical team will be made aware of need for dressing change.Also informed mom of possible need for chest x-ray to confirm correct placement of picc.Mom verbalized understanding." additional info.Received 08/19/2020: "was there patient harm reported?: 'yes, severity unknown"."what they¿re being treated for: 'transplant recipient"."0244 rn notified md via alpha page of statlock malfunction causing picc dressing to lift (requiring a picc dressing change) and of catheter exposure of approximately 1 cm.Md called rn back, no new orders at this time.No medications due to be infused until 1300, md stated she would notify pt's primary team of catheter exposure during sign out." "rn obtained a picc plus statlock (lot # juer0726) from supply room, removed statlock device from package, and were able to easily pull plastic wings off of pad (which sticks to pt's skin)." this report addresses the device that was from the supply room and not used on the patient.

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 statlock base separating from the adhesive pad is confirmed but the exact cause remains unknown.Two picc plus statlock securement devices were returned for investigation in opened packaging.The packaging on two of the devices contained lot: juer0726.One photo sample was also returned which appeared to show one unaffected device besides a statlock device with a detached retainer.The photo appears to depict the issue experienced on the two returned samples.Tactile evaluation of the adhering surfaces revealed adhesive to be present and active.Microscopic observation of the two samples revealed the presence of adhesive between the contact surfaces of the pad and retainer.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.Based on the condition of the returned samples, possible contributing factors include forces applied during handling and chemical weakening of adhesive.Since the returned components were returned with retainers detached from the foam pad, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of juer0726 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (juer0726) have been reported from the same facility.

Event Description

"0147 - pt's mother called rn stated pt's picc dressing was no longer intact.Rn went to bedside to assess picc site, found bottom of dressing to be lifted.Mother held pt's arm to prevent movement of picc line.Rn notified mother would be back shortly to perform dressing change." "0155-0225 - rn went back to bedside with rn, rn, and rn to perform picc dressing change.Upon closer examination, found picc plus statlock had malfunctioned (plastic wings while still attached to picc had lifted up off of statlock pad).Dressing and statlock device removed, noted that approximately 1cm of catheter was exposed.Rn asked mother if more of the catheter appeared to be exposed since last dressing change.Mom stated that it looked about the same, possibly a little longer.Picc dressing change performed including new statlock device (picc plus pediatric).Rn notified pt's mother that medical team will be made aware of need for dressing change.Also informed mom of possible need for chest x-ray to confirm correct placement of picc.Mom verbalized understanding." additional info.Received 08/19/2020: "was there patient harm reported?: 'yes, severity unknown." "what they¿re being treated for: 'transplant recipient." "0244 - rn notified md via alpha page of statlock malfunction causing picc dressing to lift (requiring a picc dressing change) and of catheter exposure of approximately 1 cm.Md called rn back, no new orders at this time.No medications due to be infused until 1300, md stated she would notify pt's primary team of catheter exposure during sign out." "rn obtained a picc plus statlock (lot # juer0726) from supply room, removed statlock device from package, and were able to easily pull plastic wings off of pad (which sticks to pt's skin)." this report addresses the device that was from the supply room and not used on the patient.

• Brand Name: STATLOCK PICC PLUS CRESCENT SLIDING POST
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10518255
• MDR Text Key: 206945703
• Report Number: 3006260740-2020-03210
• Device Sequence Number: 1
• Product Code: FOX
• UDI-Device Identifier: 00801741082948
• UDI-Public: (01)00801741082948
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: N/A
• Device Catalogue Number: PIC0220
• Device Lot Number: JUER0726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR