MAUDE Adverse Event Report: POSEY PRODUCT FOAM LIMB HOLDER; RESTRAINT, PROTECTIVE

Model Number 2532

Device Problems Labelling, Instructions for Use or Training Problem (1318); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Customer contacted us via e-mail.The customer states "i wanted to share this with you from this past weekend.We have had 3 self extubations this last weekend and the icu and sicu are requesting that this be reported.The patient information is below from the icu staff.They all were wearing the 2532 wrist restraints.The lot number in icu was 0365t092 and the lot number in sicu was 1062t037.None of the original restraints were kept.The following is the report from the icu: self-extubation (b)(6) 2021 @ 1805 - (b)(6) self-extubation (b)(6) 2021 @ 1200 - (b)(6) both patients were just repositioned prior to self-extubation.Staff ensured restraints had little slack, as both patients were on minimal sedation.Staff noticed that patients had additional slack on the restraint that was not there several minutes prior after repositioning when entering the room after self-extubation.Both patient's had favorable outcomes and did not require reintubation.I know sicu also had a self-extubation on (b)(6) 2021, but i do not know the circumstances around it.If find it odd that there were 3 self-extubations within 2 days.Self-extubations are typically rare, maybe a handful a year.Our practice of using restraints has not changed and, as stated above, staff was just in the patient's room prior to the self-extubation.Thank you for your efforts on trying to resolve this issue." no gtin information is available.As noted above the customer no longer has the restraints to send in for inspection.A ts template has been completed and saved to the drive.The lot #'s given were 0365t092 and 1062t037.

Manufacturer Narrative

Device was discarded and is not available for return or evaluation.Therefore, this report is based solely on the information provided by the customer.A historical review of the complaint database revealed similar complaints for this part number of unintended patient release over the last 2 years.Of those returned, broken clips, excessive force, and/or wear and tear has contributed to the malfunction.Additionally, user error related to misapplication of the device per the instructions for use or use with incorrect patient population were found to have contributed to several such complaints.There were several complaints received for straps slipping which were determined to be due to manufacturing issues that have been addressed via the capa system.A review of the device history record did not show any nonconformities and the device passed all product verification testing and met specifications when shipped.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states to before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch, broken buckles or locks, and/or that hook-and-loop adheres securely as these may allow patient to remove cuff.Discard if device is damaged or if unable to lock.The ifu also provided extra warning to not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self.Without return of the device the reported issue could not be confirmed.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no further corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).

Event Description

Supplemental medwatch being sent for additional information.

Manufacturer Narrative

Upon due diligence with the customer it was confirmed that the device was not applied in accordance with the instructions for use at the time of these events.Customer troubleshooting with the ifu was performed with customer confirmation of successful results.Formal retraining was also offered and will also be performed by tidi.Instructions for use were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states that before each use; check cuffs and straps for cracks, tears, and or excessive wear or stretch, broken buckles or locks, and or that hook and loop adheres securely as these may allow patient to remove restraint cuff.Instructions indicate to discard if device is damaged or if the device is unable securely fasten.The ifu also provided extra warning to not use this device with someone who has continued highly aggressive or combative behavior, self destructive behavior, or deemed to be an immediate risk to others or to self.Without return of the device the reported issue could not be confirmed and without the device lot information the release documentation could not be reviewed.At this time there is no evidence that a manufacturing nonconformity contributed to the reported complaint and the instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file (b)(4).

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCT; 2530 lindsay privado drive; unit a; ontario CA 91761
• MDR Report Key: 11874296
• MDR Text Key: 280753218
• Report Number: 2020362-2021-00026
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2532
• Device Catalogue Number: 2532
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1