MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS PEDI; BOTTLE, COLLECTION, VACUUM

Model Number 3612-100

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

Report received stated that the customer has a pedi oasis drain that has a wet-looking spot where the sticky dot (that holds the blue cap in place) has ¿liquefied¿ some, and bled through onto the outer side of the sleeve.It is showing through onto the outer portion of the paper, appearing wet.

Event Description

N/a.

Manufacturer Narrative

Related mfg report number: 3011175548-2023-00167; 3011175548-2023-00168; 3011175548-2023-00169.Investigation: this complaint reports that 4 pediatric oasis drains (p/n 3612-100) were found to have "wet looking spots" on the iconographic ifu, next to where the blue cap of the patient tube is held in place by adhesive.The customer explained that they opened a 3600-100 drain as well and did not find a similar mark.When asked for additional information, the customer clarified that the water ampoule was in place and was not leaking, the patient line was inside the pouch on the back of the drain, and no damage was identified on the packaging.The customer provided pictures of some of the marks on the label and the information on the label appears to still be legible.The devices have not been returned.Two cases (12 units) of the most recent lot of 3612-100 drains (lot 498576, manufactured on 07/31/2023) were examined for similar damage.7 of the 12 units had similar damage and 5 did not.It was noted for the 5 that did not have the damage that the blue cap of the patient tube was not adjacent to the circular cutout in the patient line pouch, while the others showing damage were adjacent to the cutout.From this examination, it appears possible that when the patient tube cap is adjacent to the cutout, direct contact with the iconographic ifu on the outside of the patient line pouch may be related to the damage.One case (6 units) of the oldest available lot of p/n 3612-100 (lot 489164, manufactured on 10/06/2022) was examined for similar damage.4 of the 6 devices had similar damage and 2 did not.It was noted that the staining on the iconographic ifu occurred when in contact with both the blue cap and the patient tube.A case of pediatric patient lines (p/n 011444, lot 497440) was examined to check the positioning of the patient tubes and caps and to look for any signs of alcohol or other liquid on the caps.There were 44 tube sets in the case and none of them had any sign of liquid.Of the 44 parts, 12 had the cap pushed beyond the cutout leaving the patient line covering the hole, 8 had the cap resting above the cutout so nothing was covering the hole, and in 1 the tube set had fallen about halfway out of the pouch.A simulated study was performed, where sample tubes and blue caps were placed on the adhesive part of the iconographic label inside an environmental chamber at 50% relative humidity and 50° c for three days.Both the blue cap and the tube caused marks to appear on the front side of the label, although the marks from the blue cap were more prominent and wet looking.Analysis of the tubes, caps, and label was completed which concluded that adhesive transferred from the label to the tube, but not to the cap.It was also found that terephthalate, a common thermoplastic polymer resin, from the blue cap was transferred to the label, resulting in the wet looking marks.A review of the dhr and relevant incoming inspection records was completed and no anomalies were identified.No evidence was identified to suggest that equipment, materials, or manufacturing procedures are related to this complaint.No related changes to manufacturing procedures were identified.No ncrs related to lot 494985 were identified.One ncr related to lot 491649 was identified, but it was determined to be unrelated to this complaint.The iconographic ifu was implemented for drains products in feb 2019.Subsequently on oct 29, 2021, amongst other changes, eco030716 reduced the height of the polybag that contains the patient tube set, which forced the iconographic label to be placed over the cutout in the polybag, allowing for contact between the patient tube/cap and the adhesive of the iconographic ifu.The complaint and device nonconformity are confirmed.The information reviewed in this investigation suggests the root-cause is design - dq, non-labeling.The ifu instructs the user not to use the drain if the device or packaging is damaged.A complaint history review was completed which found no related complaints.A recurring lot number report was completed which found no additional complaints against lot 494985.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 1.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending concluded that the actual occurrence level did not exceed the anticipated occurrence level.No other complaints, crs, capas, ncrs, or scars were identified.No evidence was identified to suggest that this complaint is related to manufacturing procedures, equipment, materials, or instructions for use.The most likely root-cause of this complaint is the design of the device.The dfmeca for this device adequately covers this complaint.Because the root-cause has been determined to be the design of the device, this investigation has been escalated to cr 902943.H3 other text : device not returned.

• Brand Name: DRAINS OASIS PEDI
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 17600122
• MDR Text Key: 321727984
• Report Number: 3011175548-2023-00164
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862111019
• UDI-Public: 00650862111019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

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 Model Number: 3612-100
• Device Catalogue Number: 3612-100
• Device Lot Number: 494985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1