|
Investigation: this investigation pertains to the following event: "the customer reported receiving the incorrect product for item #item #5303801 (3650-100) drain oasis dry suction blood.The product inside is item #512404 (3600-100) drain, single collection." the issue was reported by the va medical center (b)(6), via their distributor (b)(4).The complaint was submitted to atrium medical corporation by (b)(6), complaints specialist for (b)(4).The issue was identified prior to use of product.Through discussions with (b)(6) via email and phone, it was determined that the distributor ((b)(4)) post-processes atrium drain products into "heart procedure cart" kits for their customers.These kits contain various items needed for heart procedures.Kits are assembled, placed into a header bag with tyvek strip, sent to palletization, and then to a 3rd party logistics center and sterilized.They are stored in the factory until shipped to customers.The complaint is associated with (b)(4) heart procedure cart lot# 1489883, containing atrium oasis chest drain lot 479253, p/n 3650-100.One drain was returned by (b)(4) (the distributor) from lot# 1489883, out of a total reported qty of 15 units.This represents the total lot quantity; however, it is unknown how many actual units were affected.Only the drain was returned.The returned product contained an oasis 3600-100 drain in its tray, inside of an opened tyvek pouch with an oasis 3650-100 label, for atrium lot 479253.The ¿heart procedure cart pack a¿ component detail sheet was inside the open pouch.The blue csr wrap that would be applied by atrium, wrapping the drain inside the pouch, was not present.The drain was also face-up in the tray, and would be wrapped/packaged face down in the tray at atrium medical.Two small stickers, presumably applied to (b)(4), were present on the back of the returned pouch.These consisted of a blue dot and a yellow barcode sticker containing the atrium part number, lot number, and expiration.The returned pouch was evaluated and appears to be the pouch used in manufacturing by atrium.It had been opened at the chevron.There was no evidence it had been resealed.Both the graphics and drain body/components of the returned drain confirmed it to be a 3600-100 drain.The complaint submitted included reference to two atrium lot numbers: 479253 and 484519.Only labeling associated with lot 479253 (p/n 3650-100) has been observed via the returned device and photographs provided.(b)(6) indicated that the lot numbers provided were based on two lot numbers that were recorded in the device history record as being used for the (b)(4) kits for (b)(4) lot# 1489883.A copy of the (b)(4) dhr was requested, and only a portion of the dhr was provided.The two atrium lot numbers specified in the complaint were confirmed to be listed on the dhr.The lot information is as follows: lot 479253, p/n 3650-100 oasis bru, mfg date jan 2022.Lot 484519, p/n 3600-100 oasis single, mfg date jun 2022.The (b)(4) dhr indicates that the vendor item to be used for the kit is atrium p/n 3650-100.The provided pick ticket shows that components from both of the above lots were utilized in the build.One of the two lot numbers listed is for p/n 3600-100 drains, not p/n 3650-100 drains.The dhr additionally specifies that for the 3650-100 drains, "remove all from mfg pkg.Leave in blue wrap." in a phone conversation, (b)(6) also confirmed that the drain is to be removed from the pouch, but not the blue wrap.However, in subsequent correspondence it was stated that this did not occur for the lot in question.It is therefore unclear why the product was returned in its pouch (opened), without wrap.The affected complaint quantity was reported as "15", as this was the associated lot quantity for the (b)(4) lot# 1489883.However, it is unknown how many actual units are affected.Only the one unit returned and evaluated has been confirmed to match the reported event.Based on the distribution history to (b)(4), fulfilling a lot qty of 15 units for p/n 3650-100 would not have been possible, as they have only been supplied with 2 cases (12 units) of this part number.The device history records (dhrs) for both atrium oasis lots listed above were reviewed and no nonconformances or anomalies in the manufacturing process were identified.The retained labels in both dhrs matched the shop order information.There were no label reconciliation discrepancies noted in either lot.A review of production history shows that there were no lots of 3600-100 drains manufactured on same production line as 3650-100 lot 479253 in the surrounding timeframe.3600-100 are manufactured on a different production line.A further review of the manufacturing processes indicates that there are ample checks and balances within the process, including equipment/line setups specific to the drain model being run and both automated and manual inspections that would detect a product mix.There have been no other complaints received for either affected atrium lot number, and no other similar complaints (any lot) received in the last 15 months.There have been no related production nonconformances (ncrs) or corrective actions identified in the last two years.Root cause summary: based on the atrium dhr review, manufacturing review, historical review and details provided, there is no evidence to conclude a product mix occurred in the factory.Each production run requires the manufacturing line to be set up for a specific product code/family.There are ample detection points for a product mix during the manufacturing process up through the time drains are wrapped.Per conversations with (b)(4), drains are being reprocessed into kits.There is evidence in the (b)(4) dhr that the affected lot had the incorrect part number picked for some quantity of units; the part number that was stated to have been in the incorrect packaging.Per the dhr, drains are intended to be removed from their manufacturer's packaging.Therefore, there is opportunity for a lot mix to have occurred during this kitting process.Although it remains unclear why the device was returned in an open pouch without wrap due to conflicting details received, the most likely cause of this complaint is that product from the two lots was mixed during the kitting process at (b)(6) medical.Root cause is third party service.Related files: 3011175548-2022-00411, 3011175548-2022-00414, 3011175548-2022-00415, 3011175548-2022-00416, 3011175548-2022-00417, 3011175548-2022-00418, 3011175548-2022-00419, 3011175548-2022-00420, 3011175548-2022-00421, 3011175548-2022-00422, 3011175548-2022-00423, 3011175548-2022-00425, 3011175548-2022-00426, 3011175548-2022-00427.H3 other text : device not returned by distributor/customer.
|
