MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AEROSOL POCKET CHAMBER,10 PACK; NEBULIZER

Catalog Number 1001-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Aspiration/Inhalation (1725); No Consequences Or Impact To Patient (2199); Anxiety (2328)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The daughter of an elderly female alleges that the neoprene like valve detached from the pocket chamber and was sucked down the patient's (mother's) throat during a medication treatment.Intervention - the daughter patted the patient (mother) on the back to dislodge the valve.The patient ultimately coughed up the small neoprene like valve on her own.

Manufacturer Narrative

(b)(4).Date of this report:.- corrected to (b)(4) 2015.The sample was not returned for evaluation; therefore, the complaint could not be confirmed.At this time, the supplier (n'spire health) can only verify that since 2009, there have been a total of thirteen (13) complaints for all aerosol pocket chambers, with only two (2) of these complaints involving the neoprene valve coming loose from the chamber, and this is the first case where a patient actually breathed the part in.Over this same time period, the supplier has shipped (b)(4) total units for all models of the aerosol pocket chambers.This calculates to a (b)(4) overall failure yield, and a (b)(4) failure yield for this particular issue of the valve coming loose from the housing.As a side note, in march of 2014, a test fixture was added to the manufacturing process to ensure that the valves are fully seated in the chamber as they are processed.At the time of the notification of the complaint, the supplier reports that everything in process was put on qa hold for both the 1001-10 and 1001-50 units.These units get a visual inspection to ensure other remarks: the retaining nipple in the center of the valve is all the way down and seated properly, and in addition, they are subjected to a pneumatic air blast fixture at 40 psi to ensure they are not loose and the nipple is securely in place.No product from the affected lot# 522015 was available for inspection at nspire health; therefore, a random check of the chambers of two (2) different lots that were at nspire at the time of the incident report, revealed no additional loose valves through vigorous shaking in the attempt to dislodge the valve.Based on the calculated failure yields, the evaluation of the manufacturing process by quality, the finding of (o) rejects during the testing done by the manufacturing and quality groups of the units that were in process at the time of the incident, and the check of units in stock at nspire health; the conclusion is that this was an isolated event, with little chance of it being repeated.Without the actual pocket chamber and valve, no further testing could be performed, and the complaint could not be confirmed.According to the patient, this particular chamber was used for a period of three (3) months, five (5) times per day, and the unit was cleaned daily by rinsing it with running water and letting it air dry.According to the patient, no other cleaning agent, (or utensils, brushes, etc.) were used in the cleaning process which may have worn the valve nipple or dislodged it as part of the cleaning process.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.

Event Description

The daughter of an elderly female alleges that the neoprene like valve detached from the pocket chamber and was sucked down the patient's (mother's) throat during a medication treatment.Intervention - the daughter patted the patient (mother) on the back to dislodge the valve.The patient ultimately coughed up the small neoprene like valve on her own.

• Brand Name: HUDSON AEROSOL POCKET CHAMBER,10 PACK
• Type of Device: NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck drive; research triangle park NC 27709
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5154074
• MDR Text Key: 28440547
• Report Number: 1044475-2015-00374
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1001-10
• Device Lot Number: 522015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention