MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-07-12 for NONE manufactured by .
[21262013]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21498521]
On (b)(6) 2013, mai rec'd medsun (b)(4) from (b)(6) detailing the incident of a blue tourniquet (part #r2243, in i. V. Start kit #267014) breaking during a procedure, causing a welt on the nurse's finger. Mai rec'd the fda report via (b)(4) on (b)(4) 2013. Immediate/remedial actions: mai immediately opened complaint (b)(4) and contacted (b)(6) on (b)(4) and learned that the nurse suffered only a minor injury and required no medical care whatsoever. A risk assessment was performed: potential risk if tourniquet breaks while on the pt or to clinician when stretching. Risk determined to be low due to low severity if it occurs, low frequency of occurrence, and high possibility of detection. An investigation was begun immediately. (b)(4). Root cause analysis: on (b)(4) 2013 we rec'd the returned sample from the customer and were able to confirm the breakage; however, we were not able to determine the exact root cause (s) of the breakage. Mai also examined the complaint history for this product; based on past investigations for similar complaints, some possible reasons for the breakage might be: an undetected tiny hole or notch in the tourniquet edge that tore upon stretching; incomplete dispersion of raw materials during tourniquet manufacture; low tensile strength; debris in the tourniquet; or a combination of these factors. This tourniquet was purchased from a (b)(4) supplier. As part of the investigation for a previous similar complaint, mai had sent samples of the tourniquet for testing, including examination of physical properties before and after sterilization. Results showed no significant change. Since october 2012, mai has rec'd 8 complaints for these tourniquets breaking, from various kits and lots. This is our first reported injury as a result of this issue. There have been no add'l complaints for this lot. Based on complaint history and investigation results, this is a sporadic issue, and not widespread. Corrective actions: supplier was immediately notified regarding the complaint. According to the supplier, test results for one lot, although meeting specs, were in the low end of the range, so mai quarantined that lot until disposition could be determined. Supplier made changes to the tourniquet formulation that increased the tensile strength and has also instituted more frequent inspections and testing. Mai rec'd preliminary testing data and samples of the improved tourniquets. These were also examined by mai and confirmed to show excellent results: greater peak force and elongation exceeding the factory contract minimum peak force of 1600 psi. (b)(4). In addition, mai receives test results prior to releasing shipments to mai.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030451-2013-00003 |
| MDR Report Key | 3234199 |
| Report Source | 00 |
| Date Received | 2013-07-12 |
| Date Mfgr Received | 2013-06-17 |
| Date Added to Maude | 2013-07-24 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEBORAH KLOOS, DIRECTOR, CORPORAT |
| Manufacturer Street | 25 HEYWOOD ROAD MINOR PROCEDURE KITS AND TRAYS SBU |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal | 28704 |
| Manufacturer Phone | 8286818820 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | LRS |
| Date Received | 2013-07-12 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-12 |