MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-05-06 for MANIFOLD KIT 77-400990 manufactured by Deroyal Industries, Inc..
[44689455]
Investigation summary: an internal complaint ((b)(4)) was received indicating that a manifold kit ((b)(4), lot number 40872031) contained loose connections that allowed air to enter the system. The sample was returned april 25, 2016, to deroyal and forwarded to the manufacturing facility for evaluation and aid in determining the root cause. The manufacturing facility has forwarded it to deroyal's plastics group for additional analysis. The plastics group received the sample may 4. The evaluation is ongoing at this time. The investigation is incomplete. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[44689456]
The customer is experiencing quality issues with the manifold kits. They said some batches are fine but others have very loose 3 port manifolds and stopcocks. They have had to tighten the 3 port manifold, which becomes loose immediately after. This allows air to be introduced to the procedure, which can be extremely dangerous. This also causes saline to leak and delays in procedures because they have to spend time getting air bubbles out of the syringe.
Patient Sequence No: 1, Text Type: D, B5
[55249409]
Root cause: the reported issue is an isolated event. Evaluation of the returned sample failed to identify a discrepancy with the manifold but confirmed a loose handle on raw material (b)(4) (stopcock 1 way). The loose handle could be due to an issue with handling or a vendor manufacturing error. Corrective action: due to the investigation and root cause determination, a corrective action has not been taken. Investigation summary: an internal complaint ((b)(4)) was received indicating that a manifold kit (finished good (b)(4), lot number 40872031) contained loose connections that allowed air to enter the system. The sample was returned april 25, 2016, to deroyal and forwarded to the manufacturing facility for evaluation and aid in determining the root cause. The manufacturing facility has forwarded it to deroyal's plastics group for additional analysis. The plastics group received the sample may 4. The manifold did not leak during testing. However, a loose handle was identified on raw material (b)(4). Raw material (b)(4) (stopcock 1 way) is supplied to deroyal by (b)(4). It could not be confirmed if the loose handle is due to a vendor manufacturing issue or a handling issue. Deroyal has sold (b)(4) each of this stopcock component from 2014 to present. No previous issues were identified as occurring for this raw material. Therefore, a supplier notification letter was issued to (b)(4). The work order was reviewed for discrepancies that may have contributed to the reported issue. No discrepancies were identified that could have contributed to the reported failure. Preventive action: due to the investigation and root cause determination, a preventive action has not been taken. The investigation is complete. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[55249410]
The customer is experiencing quality issues with the manifold kits. They said some batches are fine but others have very loose 3 port manifolds and stopcocks. They have had to tighten the 3 port manifold, which becomes loose immediately after. This allows air to be introduced to the procedure, which can be extremely dangerous. This also causes saline to leak and delays in procedures because they have to spend time getting air bubbles out of the syringe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2016-00005 |
| MDR Report Key | 5637653 |
| Report Source | USER FACILITY |
| Date Received | 2016-05-06 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-04-08 |
| Date Mfgr Received | 2016-04-08 |
| Date Added to Maude | 2016-05-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1501 EAST CENTRAL AVENUE |
| Manufacturer City | LAFOLLETTE TN 37766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37766 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANIFOLD KIT |
| Generic Name | ANGIOGRAPHY/ANGIOPOLASTY KIT |
| Product Code | OEQ |
| Date Received | 2016-05-06 |
| Returned To Mfg | 2016-04-25 |
| Catalog Number | 77-400990 |
| Lot Number | 40872031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 1501 EAST CENTRAL AVENUE LAFOLLETTE TN 37766 US 37766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-06 |