MAUDE Adverse Event Report: COVIDIEN WARMERS, INFANT HEEL W0/TABS; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number	MH00002N
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that their lab team reported a skin puncture from the infant heel warmer.The lab manager reported that one of their blood collectors was using this product and a piece of hardened gel from the interior pierced the bag and stuck in her finger.It was a small laceration which was not contaminated.No treatment was required.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One picture was provided for the evaluation.Upon visual evaluation, the provided picture does not clearly show an issue.There were few potential root causes established from a root cause analysis perspective: ¿ first potential cause could be due to a solid piece of sodium acetate formed resulting in a sharp edge which somehow pierced the pouch.¿ second potential root cause could be due to an issue in the raw material pouch stock resulting in a thin spot which allowed some of the sodium acetate to break through.¿ third potential root cause could be due to a possible foreign debris landed in the pouch from the machine.A review of risk assessment was performed with maintenance and engineering showed no risk associated with the sodium acetate crystalizing and becoming sharp enough to break through the pouch.The dry/powder sodium acetate is also sifted prior to being introduced to the machine to further reduce this possibility.Without the physical sample, it is difficult to determine what could have caused the laceration as described by the customer.The results of the manufacturing facility investigation were able to determine that the likely root causes of the issue are manufacturing related.A quality alert has been issued to raise awareness of quality issue related to this complaint.A corrective action is not applicable at this time.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: WARMERS, INFANT HEEL W0/TABS
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 11148335
• Report Number: 1219103-2021-00310
• Device Sequence Number: 3472200
• Product Code: MPO
• UDI-Device Identifier: 30884527004625
• UDI-Public: 30884527004625
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: No Information
• Device Model Number: MH00002N
• Device Catalogue Number: MH00002N
• Device Lot Number: 007630X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 03/02/2021
• Patient Sequence Number: 1